Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The main component of the substance “Reaction product of lead chloride or lead sulphate with alkaline solution” is lead (Pb). Pb salts used as source material are waste materials produced by Pb battery recycling process or by-products of the hydrometallurgical upgrading of PGM rich lead bullion. This transported isolated intermediate is produced under strictly controlled conditions, exposure is controlled by existing RMMs taken place in production processes and intermediate use under strictly controlled conditions (section 11). Further hazard assessment is therefore unnecessary. It is an inorganic solid UVCB-substance having ~85% of particles smaller than 400 µm. The major and the most hazardous constituent of this intermediate is lead (conc. >50 %) which is determined to be poorly water soluble (section 4.8, EU method A.6).

Studies for irritative properties testing were performed with three selected lead compounds on an exemplary basis: lead oxide, dibasic lead phosphite and dibasic lead phthalate (Bien, 2003a,b,c). Rationality for selecting these compounds is exposure within industry, compound with inorganic anion and low solubility and compound with an organic anion with relatively high solubility, respectively. Lead compounds did not exhibit irritative properties.

The classification is based on the composition of “Reaction product of lead chloride or lead suphate with alkaline solution” (see section 4.23), and assessed by using C&L rules for mixtures. All constituents in this intermediate having classification entries in CLP Annex VI were considered.  As a worst-case assumption all relevant compounds are considered leachable i.e. bioavailable.  The 100% distribution means that e.g. when 50 % Pb is present that all of it (100%) is allocated to the form of 'Pb compounds' and not a certain amount as e.g. PbCO3, which could result in a different classification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August-December 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Well-documented and corresponded to the requirements of the recommended Annex V test guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
There was one deviation from the study protocol which was concerned with the relative humidity (section 6.2 Husbandry). On some days of the study the relative humidity was higher than 70%.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 2.74. 2.75 and 3.26 kg.
- Housing: The rabbits were housed individually in a battery of cages with a cage size of 100 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet ad libitum
- Water (e.g. ad libitum): Tap water as used for human consumption was continuously available ad libitum.
- Acclimation period: The animals were acclimatised to laboratory conditions for more than 5 days. Animals have been housed at the testing facility for 20 days or several months.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees centigrade
- Humidity (%): 44-72%
- Air changes (per hr): 16 times/h and filtered adequately
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light with light on at 7:00 AM


IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
The skin of the back of all animals was clipped 24 h before treatment and examined for potential lesions.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
Skin reactions were assessed 1, 24, 48 and 72 hours after the end of the exposure.
Number of animals:
Three animals
Details on study design:
TEST SITE
- Area of exposure: Right side of the back. The untreated left side served as a control.
- % coverage:
- Type of wrap if used: The test article was applied to a gauze patch and then applied to the skin.


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM:
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
very slight signs of erythema observed 1 hour after patch removal
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
very slight signs of erythema observed 1 hour after patch removal
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
very slight signs of erythema observed 1 hour after patch removal
Irritant / corrosive response data:
Very slight signs of erythema were seen 1 hour after patch removal in all three animals. Thereafter, no signs of erythma or oedema were observed. The mean grades at 24, 48 and 72 hours after the end of exposure were "0" in each animal.
Other effects:
No toxic effects with respect to the general condition were observed.

Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.

See IUCLID Section 13 for Analogue approach report.

Interpretation of results:
GHS criteria not met
Conclusions:
The test article was classified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure according to the criteria specified by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "ALLSTAB LP 3139 dibasic lead phosphite" is classified as "non-irritant".
Executive summary:

The potential toxicity of "ALLSTAB LP 3139 dibasic lead phosphite" was assessed in an acute dermal irritation/corrosion test on three albino rabbits. In each animal, 0.5 g of the solid test article was applied on the right side of the dorsal clipped region, the untreated left side served as the control. Exposure duration was 4 hours. Both sides were examined at 1, 24, 48 and 72 hours after the end of exposure. The following results were obtained: -There were no skin irritating findings with the exception of very slight erythema observed 1 hour after patch removal in all three animals. -No general toxic effects were seen. -The mean grades at 24, 48 and 72 hours after the end of exposure were "0" in each animal. The test Article was classified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure according to the criteria specified by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "ALLSTAB LP 3139 dibasic lead phosphite" is classified as "non-irritant".

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August-December 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Well-documented and corresponded to the requirements of the recommended Annex V test guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
There was one deviation from the study protocol which was concerned with the relative humidity (section 6.2 Husbandry). At some days of the study the relative humidity was higher than 70%.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 2.67, 2.84 and 3.86 kg
- Housing: The rabbits were housed individually in a battery of cages with a cage size of 100 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet (pelleted diet, batch no. K088) offered ad libitum.
- Water (e.g. ad libitum): Tap water as for human consumptiion was continuously available ad libitum via drinking nipples.
- Acclimation period: The animals were acclimatised to laboratory conditions for more than 5 days. Animals were housed at the testing facility for 20 days or several months


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees centigrade
- Humidity (%): The relative humidity was kept between 44 and 72%.
- Air changes (per hr): Air was changed 16 times per hour and filtered adequately.
- Photoperiod (hrs dark / hrs light):12 hours dark/12 hours light with light on at 7:00 AM


IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
The skin of the back of all animals was clipped 24 hours before treatment and examined for potential lesions. Only healthy animals showing no evidence of abnormalities were allocated to the test.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after exposure
Number of animals:
three albino rabbits
Details on study design:
TEST SITE
- Area of exposure: Clipped skin on the right side of the back of rabbit
- % coverage:
- Type of wrap if used: Gauze patch


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM:
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
very slight signs of erythema observed 1 hour after patch removal
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
very slight signs of erythema observed 1 hour after patch removal
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
very slight signs of erythema observed 1 hour after patch removal
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no skin irritating findings with the exception of very slight signs of erythema observed 1 hour after patch removal in all three animals.
The mean grades at 24, 48, and 72 hours after the end of exposure were "0" in each animal.
Other effects:
No general toxic effects were seen

Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.

See IUCLID Section 13 for Analogue approach report.

Interpretation of results:
GHS criteria not met
Conclusions:
The test article was classsified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure accordingto the EEC Directive 2001/59/EEC of 6 August 2001 and Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied tothe skin, the test article "LITHARGE lead oxide" is classified as "non-irritant."
Executive summary:

The potential toxicity of "LITHARGE lead oxide" was assessed in an acute dermal irritation/corrosion test on three albino rabbits. In each animal, 0.5 g of the solid test article was applied on the right side of the dorsal clipped region, the untreated left side served as control. Exposure duration was 4 hours. Both sides were examined at 1, 24, 48, and 72 hours after the end of exposure. The following results were obtained:

-No signs of erythema and oedema were observed

-No general toxic effects were seen

-The mean grades at 24, 48, and 72 hours after the end of exposure were "0" in each animal.

The test article was classsified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure according to the EEC Directive 2001/59/EEC of 6 August 2001 and Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When applied to the skin, the test article "LITHARGE lead oxide" is classified as "non-irritant."

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August-December 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Well-documented and corresponded to the requirements of the recommended Annex V test guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
There was one deviation from the study protocol which was concerned with the relative humidity (section 6.2 Husbandry). On some days of the study the relative humidity was higher than 70%.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 2.97, 3.09, 3.26 kg
- Housing: The rabbits have been housed individually in a battery of cages with a cage size 100 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet (pelleted diet, batch no. K088). Offered ad libitum.
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking nipples.
- Acclimation period: The animals were acclimatised to the laboratory for more than 5 days. Animals were housed at the testing facility for 20 days or several months.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- degrees centigrade
- Humidity (%): 44-72%
- Air changes (per hr): Air was changed about 16 times per hour and filtered adequately.
- Photoperiod (hrs dark / hrs light):12 hrs dark/12 hrs light with light on at 7:00 AM


IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
The skin of the back of all animals was clipped 24 hours before treatment and examined for potential lesions.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, and 72 hours after the exposure period.
Number of animals:
Three male rabbits
Details on study design:
TEST SITE
- Area of exposure: The right side of the back of the rabbit.
- % coverage:
- Type of wrap if used: The test article was applied to a gauze patch and then applied to the skin. To ensure good contact with the skin, 2-3 drops of peanut oil were used. The closed patch exposure was effected by means of a semi-occlusive bandage using Ypsiplast , nonirritating tape Elastoplast and Stulpa, which enveloped the whole of the animal's trunk.


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM:
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
No signs of erythema or oedema were observed.
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
No signs of erythema or oedema were observed.
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
No signs of erythema or oedema were observed.
Irritant / corrosive response data:
No signs of erythema or oedema were observed. The mean grades at 24, 48 and 72 hours after the end of exposure were "0" in each animal.
Other effects:
No toxic effects with respect to the general condition were observed.

Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.

See IUCLID Section 13 for Analogue approach report.

Interpretation of results:
GHS criteria not met
Conclusions:
The test article was classified on the basis of the mean values of skin reactions 24,48, and 72 hours after the end of the 4-hour exposure according to the criteria specified by the EEDC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1.I, p.2233). When applied to the skin, the test article is classified as "non-irritant".
Executive summary:

The potential toxicity of "PEBETAL dibasic lead phthalate" was assessed in an acute dermal irritation/corrosion test on three albino rabbits. In each animal, 0.5 g of the solid test article was applied on the right side of the dorsal clipped region, the untreated ledt side served as control. Exposure duration was 4 hours. Both sides were examined at 1, 24, 48 and 72 hours after the end of exposure.

The following results were obtained:

-No signs of erythema and oedema were observed.

-No general toxic effects were seen.

-The mean grades at 24, 48 and 72 hours after the end of exposure were "0" in each animal.

The test article was classified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4 -hour exposure according to the criteria specified by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefDtoffV) of 15 November 1999 (BGB1.I, p.2233). When applied to the skin, the test article "PEBETAL dibasic lead phthalate" may therefore be classified as "non-irritant".

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.
See IUCLID Section 13 for Analogue approach report.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
This conclusion is based on the results of the in vivo studies performed the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate).
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
This conclusion is based on the results of the in vivo studies performed the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate).
Interpretation of results:
GHS criteria not met
Conclusions:
When administered to the eye, the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate) are classified as "non-irritant to the skin".
Based on the similarities between these three test articles and the target substance described in the read-across jsutification inculded in section 13, the target substance is considered to be "non-irrtant to the skin".
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August 2002-December 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Well-documented and corresponded to the requirements of the recommended Annex V test guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The health status of the animals is SPF. Animals have been housed at the testing facility for 27 days or several months. Three male rabbits. Before the animals arrived, the study room and cages were cleaned and disinfected. During the study, the room and cages were cleaned at regular intervals. The rabbits were kept individually in a battery of cages with a cage size of 100 x 45 x 40 cm (L x B x H), equipped with a paper disposal system. The room temperature was adjusted to 20 C.+/_ 3 and the relative humidity was kept between 30 and 70%. Maximum and minimum temperature and humidity were monitored daily. Artificial light was set to give a cycle of 12 hours light and 12 hours dark with light on at 7:00 a.m. Air was changed about 16 times per hour. and filtered adequately. The animals received Teklad Global Rabbit Diet. Tap water as for human consumption was continuously available ad libitum via drinking nipples.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
Three male rabbits used in the test were acclimatised to laboratory conditions for 27 days or several months. Twenty four hours before treatment, the eyes of all animals were examined for potential ocular lesions. Since the animals did not show ocular abnormalities, they were allocated to the test. The solid test article was used as supplied by the Sponsor. One of the animals (rabbit no.1) was treated in advance in order to assess ocular reactions to the test article. The animal was treated with 0.1 g of the solid test article, which was introduced into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about 1 sec in order to limit loss of the test article. The untreated left eye served as the control. Since there was no remarkable response to the instillation of the test article within a few days, the further two animals were treated subsequently in the same manner. Ocular reactions were assessed 1, 24, 48, and 72 hours after instillation according to the "Grades for ocular lesions." In addition to the examination of the eyes, general clinical observation was conducted.
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Redness of the conjunctivae, grade 1 or 2, were observed in the animals at 1 hour after instillation. These findings were still apparent in two out of the three animals until 24 or 48 hours after instillation.
Additionally, slight discharge was observed in all animals at 1 hour after instillation and in one out of three animals also at 24 hours after instillation.
The mean grades were 0.0, 1.00 and 1.00 for redness of the conjunctivae and 0.0, 0.67and 0.33 for chemosis of the conjunctivae.
Other effects:
No general toxic effects were observed. The observed findings were fully reversible 72 hours after instillation in all animals.

The mean grades of ocular reactions at 24, 48, and 72 hours after instillation were lower than classified as irritant by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233).

Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.

See IUCLID Section 13 for Analogue approach report.

Interpretation of results:
GHS criteria not met
Conclusions:
The mean grades of ocular reactions at 24, 48 and 72 hours after instillation were lower than the value classified as irritant by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When administered to the eye, the test article "ALSTAB LP 3139 dibasic lead phosphite" may be classified as "non-irritant."
Executive summary:

The potential toxicity of "ALSTAB LP 3139 dibasic lead phosphite" was assessed in an acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1g of the test article was introduced into the conjunctival sac of the right eye, the untreated left eye served as control. Both eyes were examined at 1, 24, 48 and 72 hours post applicationem. The following results were obtained:

Redness and chemosis of the conjunctivae, grade 1 nad 2, were observed in the animals at 1 hour after instillation. These findings were still apparent in two out of the three animals until 24 or 48 hours after instillation. Additionally, slight discharge was observed in all animals at 1 hour after instillation and in one out of three animals also at 24 hours after instillation. No general toxic effects were observed. The observed ocular findings were fully reversible 72 hours after instillation in all animals. The mean grades were 0.0, 1.00, and 1.00 for redness of the conjunctivae and 0.0, 0.67 and 0.33 for chemosis of the conjunctivae.

The mean grades of ocular reactions at 24, 48, 72 hours after instillation were lower than the value classified as irritant by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGN1. I, p.2233). When administered to the eye, the test article "ALSTAB LP 3139 dibasic lead phosphite may be classified as "non-irritant."

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August 2002-December 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Well-documented and corresponded to the requirements of the recommended Annex V Test Guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 2.67, 3.00 and 3.84 kg
- Housing: Rabbits kept individually in a battery of cages with a cage size of 100 x 45 x 40 cm equipped with a paper disposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet (pelleted diet) offerred ad libitum. Batches of diet are analysed periodically for a wide range of contaminants by Harlan Teklad
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking nipples. Samples of drinking water are subjected periodically to bacteriological tests and to chemical analyses, including the determination of chlorinated hydrocarbons, heavy metals, and arsenic.
- Acclimation period: animals have been housed at the testing facility for 27 days or several months


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 degrees C +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): 16 times/hour
- Photoperiod (hrs dark / hrs light):12/12 with light on at 7:00 AM


IN-LIFE DATES: From: To:
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
Three male rabbits used in the test were acclimatised to laboratory conditions for 27 days or several months. Twenty four hours before treatment, the eyes of all animals were examined for potential ocular lesions. Since the animals did not show ocular abnormalities, they were allocated to the test.The solid article was used as supplied by the Sponsor. One of the animals (rabbit no.1) was treated in advance in order to assess ocular reactions to the test article. The animal was treated with 0.1g of the solid test article, which was introduced into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about 1 second in order to limit loss of the test article. The untreated left eye served as the control. Since there was no remarkable response to the instillation of the test article within a few days, the further two animals were treated subsequently in the same manner.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Slight redness (grade 1) of the conjunctiva occurred in animal no.1 at 1 h after instillation and disappeared subsequently. No ocular findings were seen between 24 h after instillation and the end of observation 72 h after instillation. The mean grades of erythema at 24, 48 and 72 h after instillation were "0" in all animals.
Other effects:
No general toxic effects were observed.

Lead oxide is a non-irritant.

Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.

See IUCLID Section 13 for Analogue approach report.

Interpretation of results:
GHS criteria not met
Conclusions:
The test article was classified according to the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GEfStoffV) of 15 November 1999 (BGB1, p.2233). When administered to the eye, the test article is classified as "non-irritant."
Executive summary:

The purpose of this study was to assess irritant and/or corrosive effects of LITHARGE lead oxide on eyes and associated mucous membranes following ocular administration to rabbits. Information derived from this test serves to indicate the existence of possible hazards likely to arise from exposure of the eye to the test article.

The potential toxicity of LITHARGE lead oxide was assessed in an acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1g of the test article was introduced into the conjunctival sac of the right eye, the untreated left eye served as control. Both eyes were examined at 1, 24, 48 and 72 hours post applicationem. The following results were obtained:

Between 24 and 72 hours after instillation no ocular findings were seen. The only finding was slight redness of the conjunctivae in one animal 1 h after instillation.

No general toxic effects were observed.

The mean grades of ocular reactions 24, 48 and 72 hours after instillation were "0" in each animal.

The test article was classsified according to the EEC directive 2001/59/ECC of 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233). When administered to the eye, the test article LITHARGE lead oxide may therefore be classified as "non-irritant."

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August 2002-December 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. Well-documented and corresponded to the requirements of the recommended Annex V Test Guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation:
- Weight at study initiation: 3.11, 3.25, and 3.27 kg
- Housing: Cage size of 100 x 45 x 40 cm (L x B x H), equipped with a paper diposal system.
- Diet (e.g. ad libitum): Teklad Global Rabbit Diet ad libitum
- Water (e.g. ad libitum): Tap water as for human consumption was continuously available ad libitum via drinking nipples
- Acclimation period: Animals used in the test were housed at the testing facility and acclimatised for 27 days or several months


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degrees Centigrade
- Humidity (%): between 30-70%
- Air changes (per hr): 16/hr and filtered adequately
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light with light on at 7:00 AM


IN-LIFE DATES: From: To:
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g of the solid test article
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours - 7 days
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
Three male rabbits used in the test were acclimatised to laboratory conditions for 27 days or several months. Twenty four hours before treatment, the eyes of all animals were examined for potential ocular lesions. Since the animals did not show ocular abnormalities, they were allocated to the test.

The solid test article was used as supplied +by the sponsor. One of the animals was treated in advance in order to assess ocular reactions to the test articles. The animal was treated with 0.1 g of the solid test article, which was introduced into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about 1 sec in order to limit loss of the test article. The untreated left eye served as control. Since there was no remarkable response to the instillation of the test article within a few days, the further two animals were treated subsequently in the same manner. Ocular reactions were assessed 1,24,48, and 72 hours after instillation and thereafter once daily up to day 7 according to the "Grades for ocular lesions." In addition to the examination of the eyes, general clinical observation was conducted. Ocular reactions were classified on the basis of calculated mean grades at 24,48 and 72 hours after treatment according to the EEC Directive 2001/59/EEC of 6 August
2001 and Gefahrstoffverordnung (GefStoffV) 0f 15 November 1999 (BGB1. I, p.2233).
+
Irritation parameter:
chemosis score
Remarks:
chemosis of the conjunctivae
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Remarks:
No swelling
Irritation parameter:
chemosis score
Remarks:
chemosis of the conjunctivae
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Remarks:
No swelling
Irritation parameter:
chemosis score
Remarks:
chemosis of the conjunctivae
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
positive indication of irritation
Remarks:
Obvious swelling with partial eversion of lids
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
probability of weak irritation
Remarks:
Some blood vessels, definitely hyperaemic
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
probability of weak irritation
Remarks:
Some blood vessels, definitely hyperaemic
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
2.33
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
positive indication of irritation
Remarks:
Diffuse, Crimson colour, individual vessels not easily discernible
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 7 days after instillation
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Moderate redness of the conjunctivae (grade 2) was observed in all three animals at 1 hour after instillation. This finding was still apparent at 24 and 48 hours after instillation in animals no.1 and 2 or up to day 6 after instillation in animal no.3, evaluated with grade 3 at 24 hours after treatment. Discharge (grade 1 or 2) was seen in the animals at 1 hour after instillation and was still observed in animal no.3, evaluated with grade 3 at 24 hours
after treatment. Discharge (grade 1111 or 2) was seen in animals at 1 hour after instillation and was still observed in animal no.3 at 24 hours after instillation. Additionally, bloody vessels of the eyeball were seen in animal no.3 at 24 hours up to day 5 adter instillation. In all animals, no ocular findings were seen at day 7 after instillation.
Other effects:
No general toxic effects were observed. The observed ocular findings were fully reversible within 7 days after instillation.

 

Mean values of ocular reactions at 24, 48 and 72 hours after treatment (test eye) R

 Cornea  Iris  Conjunctivae Redness  Conjunctivae Chemosis
 Rabbit 1 0.00 0.00 1.00 0.67
 Rabbit 2 0.00 0.00  1.00 0.33 
 Rabbit 3 0.00  0.00   2.33 2.00 

Key:

Conjunctivae redness 1.00 - Some blood vessels definitely hyperaemic

2.00- Diffuse, Crimson colour, individual vessels not easily discernible

Conjunctivae chemosis 0 -No swelling; 1.00 Any swelling above normal; 2.00 Obvious swelling with partial eversion of lids

Interpretation of results:
GHS criteria not met
Conclusions:
The mean grades of ocular reactions at 24, 48 and 72 hours after instillation were lower than the value classified as irritant by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstoffverordnung (GefffStoffV) of 15 November 1`999 (BGB1. I, p,2233). When administered to the eye, the test article "PEBETAL dibasic lead pthalate" may be classified as "non-irritant."
Executive summary:

The potential toxicity of "PEBETAL dibasic lead phthalate" was assessed in an acute eye irritation/corrosion test on 3 albino rabbits. In each animal, 0.1 g of the test article was introduced into the conjunctival sac of the right eye, the untreated left eye served as control. Both eyes were examined at 1, 24, 48, and 72 hours post applicationem.

The following results were obtained;

Redness and chemosis of the conjunctivae, grade 2, were observed in the animals 1 hour after instillation and in one rabbit up to day 5 or 6 after instillation. Moderate discharge was observed in all animals at 1 hour after instillation and was seen in one out of three animals also at 24 hours after instillation. Additionally, bloody vessels of the eyeball were seen in one animal between 24 hours and day 6 after instillation.

No general toxic effects were observed.

The observed ocular findings were fully reversible within 7 days after instilllation in all animals.

The mean grades of findings were 1.00, 1.00, and 2.33 for redness of the conjunctivae and 0.67, 0.33 and 2.00 for chemosis of the conjunctivae

The mean grades of ocular reactions at 24,48 and 72 hours after instillation were lower than the value classified as irritant by the EEC Directive 2001/59/EEC of 6 August 2001 and the Gefahrstofffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p.2233) When administered to the eye, the test article "PEBETAL dibasic lead phthalate" may be classified as "non-irritant."

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.
See IUCLID Section 13 for Analogue approach report.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
This conclusion is based on the results of the in vivo studies performed the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate).
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
This conclusion is based on the results of the in vivo studies performed the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate).
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
This conclusion is based on the results of the in vivo studies performed the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate).
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Remarks:
This conclusion is based on the results of the in vivo studies performed the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate).
Other effects:
No general toxic effects were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
When administered to the eye, the 3 test articles (Lead monoxide, [phthalato(2-)]dioxotrilead and trilead dioxide phosphonate) are classified as "non-irritant to the eye".
Based on the similarities between these three test articles and the target substance described in the read-across jsutification inculded in section 13, the target substance is considered to be "non-irrtant to the eye".
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance “Reaction product of lead chloride or lead sulphate with alkaline solution” consists mainly of lead and therefore read-across is based on properties of lead. Justification for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly water soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects. See IUCLID Section 13 for Analogue approach report.

Reliable animal data were found indicating that lead oxide, lead phosphite and dibasic lead phthalate lack irritating properties for the skin or the eyes. The experimental data are reinforced by a lack of reports of skin or eye irritation in the many occupational exposure environments which provide opportunities for exposure of lead and sparingly soluble lead compounds to the skin and eyes (section 7.10, supportive information). Classification for these endpoints is clearly not needed. Specific studies of lung irritation were not found, but the lack of inhalation toxicity from lead oxide in both acute toxicity testing and inhalation cancer bioassays combine with an absence of reports of lung irritation in occupational settings to suggest classification is not needed (section 7.10, supportive information).

The substances for which data are available should permit data waiving for a number of other substances. The three tested compounds are all sparingly soluble and thus unlikely to undergo significant dissolution when applied to the skin, eyes or inhaled. The tested compounds further include one compound with an organic anion and one with an inorganic anion.Data waiving for all irritant classification endpoints should thus be possible for metallic lead and other sparingly soluble lead salts unless anions are present that literature searches suggest might impart irritating properties.

No studies were found documenting corrosive properties of lead and sparingly soluble lead compounds in either experimental animals or humans. Given the negative findings of acute toxicity and irritation studies and the absence of reports from occupationally exposed workers (section 7.10, supportive information), corrosive properties are not to be expected of lead or its sparingly soluble compounds.

Calculated classification was performed from all constituents in this intermediate having classification entries in CLP Annex VI (using mixture toxicity rules) with MeClas-tool. For skin irritation no major drivers were found, thus no classification.

Justification for classification or non-classification

The derived classification result for the UVCB substance with MeClas-tool using C&L mixture rules is:

CLP: not classified for irritative or corrosive properties.