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Administrative data

Description of key information

The substance is corrosive to the skin and slightly irritating to the eyes (Märtins, 1989).

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:
May 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
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: Interfauna UK Ltd.
- Age at study initiation: not specified
- Weight at study initiation: 2.8, 3.0 and 3.7 kg (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: contralateral skin part of the flank with vehicle exposure served as control
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin areas were cleaned with water
- Time after start of exposure: ca. 4 hours after start of exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 7 days
Remarks on result:
probability of severe irritation
Other effects:
The skin was indurated after 7 days in animal 3 and necrotic in animal 1.
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a dermal irritation/corrosion test the test substance formulated in water was corrosive to the skin of rabbits according to OECD TG 404. Within the 7-day post-observation period no restitution with normal skin findings at the application site were observed.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
May 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
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: Interfauna UK Ltd.
- Age at study initiation: not specified
- Weight at study initiation: 2.8, 3.0 and 3.7 kg (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: paraffin oil
Controls:
other: contralateral skin part of the flank with vehicle exposure served as control
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin areas were cleaned with water
- Time after start of exposure: ca. 4 hours after start of exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 14 days
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 14 days
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 14 days
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 14 days
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 14 days
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not reversible
Remarks:
score 4 after 14 days
Remarks on result:
probability of severe irritation
Other effects:
In all animals the skin was necrotic after 14 days.
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a dermal irritation/corrosion test the test substance formulated in paraffin oil was corrosive to the skin of rabbits according to OECD TG 404. Within the 14-day post-observation period no restitution with normal skin findings at the application site were observed.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dec 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
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: Interfauna UK Ltd.
- Age at study initiation: not specified
- Weight at study initiation: 2.8, 3.0 and 3.7 kg (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
The treated eye was rinsed with physiological NaCl solution after 24 hours.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Other effects:
none
Interpretation of results:
other: slightly irritating
Executive summary:

In an eye irritation test the test substance was slightly irritating to the eyes of rabbits according to OECD TG 405. Within the 7-day post-observation period restitution with normal eye findings were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In two dermal irritation/corrosion tests the test substance formulated in paraffin oil or water was corrosive to the skin of rabbits according to OECD TG 404. Within the 14-day or 7-day post-observation period no restitution with normal skin findings at the application site were observed (Märtins, 1989).

In an eye irritation test the test substance was slightly irritating to the eyes of rabbits according to OECD TG 405. Within the 7-day post-observation period restitution with normal eye findings were observed (Märtins, 1989).

Justification for classification or non-classification

Skin irritation

Based on the study results for skin irritation/corrosion the following classification according to Annex I of Regulation (EC) No. 1272/2008 is required: Category 1C (H314: Causes severe skin burns and eye damage).

Eye irritation

According to the Guidance on Application of Regulation (EC) No 1272/2008, chapter 3.3, if a substance is classified as Skin Corrosive Category 1 then serious damage to eyes is implicit and there is no need to proceed with classification for eye effects.