Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
other justification
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
other:
Justification for type of information:
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.1.1 (as amended by Commission Regulation (EU) 2016/863) the in vitro skin corrosion (OECD TG 431) study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (eq. or similar to OECD TG 404) skin irritation study is available and indicates that the substance is skin corrosive and a definitive conclusion on the classification can be made. Furthermore, in accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI the weight of evidence indicates that the substance is skin corrosive and therefore in vitro testing may be omitted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.
Reason / purpose:
data waiving: supporting information
Conclusions:
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.1.1 (as amended by Commission Regulation (EU) 2016/863) the in vitro skin corrosion (OECD TG 431) study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (eq. or similar to OECD TG 404) skin irritation study is available and indicates that the substance is skin corrosive and a definitive conclusion on the classification can be made. Furthermore, in accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI the weight of evidence indicates that the substance is skin corrosive and therefore in vitro testing may be omitted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.
Executive summary:

In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.1.1 (as amended by Commission Regulation (EU) 2016/863) the in vitro skin corrosion (OECD TG 431) study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (eq. or similar to OECD TG 404) skin irritation study is available and indicates that the substance is skin corrosive and a definitive conclusion on the classification can be made. Furthermore, in accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI  the weight of evidence indicates that the substance is skin corrosive and therefore in vitro testing may be omitted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1980 to June 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Test procedure performed in accordance with generally accepted scientific standards and well documented. Applicant assessment indicates that any deviation from current published guidelines would not be sufficient to affect the study outcome.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: unspecified
- Weight at study initiation: 3 - 4 kg
- Housing: Individually housed in rabbit cages.
- Diet: Standard mixed rabbit feed, ad libitum.
- Water: Water, ad libitum.
- Acclimation period: Time not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Unspecified
- Humidity (%): Unspecified
- Air changes (per hr): Unspecified
- Photoperiod: Unspecified
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Test material was used as supplied.
Duration of treatment / exposure:
1 or 8 hours
Observation period:
Immediately after treatment and for the following 7 days.
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: semi-occlusive (2.5 cm x 2.5 cm surgical gauze patch secured with surgical adhesive tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified; irrigation with water, soap and cotton wool mentioned elsewhere in the test report.
- Time after start of exposure: Not specified; immediate irrigation mentioned elsewhere in the test report.

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema _________________________________________________________________________0
Very slight erythema (barely perceptible) ________________________________________________1
Well-defined erythema ________________________________________________________________2
Moderate to severe erythema __________________________________________________________3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ________________4

Oedema Formation
No oedema __________________________________________________________________________0
Very slight oedema (barely perceptible) _________________________________________________1
Slight oedema (edges of area well-defined by definite raising) _____________________________2
Moderate oedema (raised approximately 1 millimetre) ____________________________________3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) ___4
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: All observations
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score is applicant assessment based on written description in study report.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: All observations
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 0 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Remarks:
Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 0 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Remarks:
Score is applicant assessment based on written description in study report.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score is applicant assessment based on written description in study report.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Remarks:
Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: Score is applicant assessment based on written description in study report.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Score is applicant assessment based on written description in study report.
Irritant / corrosive response data:
- Erythema: "Severe reddening with partial skin corrosion" (applicant assessment: severe erythema, score = 4) apparent immediately upon removal of bandage, persisting for the duration of the observation period, at both test sites.
- Edema: "Slightly swollen skin" (applicant assessment: Slight edema, score = 2) observed in both sites, immediately upon removal of bandage, with effects fully-reversed within 48 hours.
- Reversibility of effects: Erythema did not reverse during the observation period; oedema reversed within 48 hours.
Other effects:
There was no clinical signs of toxicity reported during the duration of the test, and no comments are recorded regarding bodyweight for these rabbits.

The study report provides written description of the reaction of the animals' skin to the test item. Applicant assessment of the written description indicates the following scores:

Table 1. Individual skin reactions  

Skin Reaction Observation Time
(following patch removal)
Individual Scores
Number and Sex
#1 (male) #2 (female)
Erythema/Eschar Formation 0 Hours 4 4
Intermediate observations 4 4
48 Hours 4 4
7 days 4 4
Edema Formation 0 Hours 2 2
Intermediate observations 2 2
48 Hours 2 2
7 days 0 0

Mean scores (N=2) per organism at 0 -48h and 7d:

0 -48h:

Erythemea/Escar Formation:

1: 4

2: 4

Edema Formation:

1: 2

2: 2

7d:

Erythemea/Escar Formation:

1: 4

2: 4

Edema Formation:

1: 0

2: 0

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item is considered very strongly irritating and corrosive to the skin.
Executive summary:

The study was performed historically to a documented method similar to OECD TG 404 and EU Method B.4, to assess the primary skin irritancy potential of the test item in New Zealand White rabbits, following single 1 or 8 -Hour, semi-occluded applications to intact rabbit skin. Applicant assessment indicates that any deviation from current guidelines would be insufficient to affect the study outcome. 0.5 g of the test item was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the clipped skin to assess the irritancy potential of the test item. The patch was secured in position with a strip of surgical adhesive tape. After 1 or 8 hours of exposure to the test item (1 treatment/exposure-period per rabbit), the patches were removed and individual dose sites were observed immediately and over the following 7 days. A single, semi occluded application of the test item, of either 1 or 8 hours, to the intact skin of two rabbits produced severe erythema and partial corrosion immediately at the two treated skin sites, which did not reverse during the study. Slight erythema was detected immediately after patch removal in both sites, which was fully reversed within 48 hours. Corrosive effects were noted. Mean scores for following grading between 0 hours and 7 days were 4 and 4 in erythema and eschar scoring criteria; mean scores for following grading between 0 hours and 48 hours were 2 in edema scoring criteria; mean scores for following grading from 48 hours to 7 days were 0 in edema scoring criteria. The study authors note "Aufgrund der stark ausgepraegten Reiz- und Aetzwirkung ist jedoch jeder Haut- und Schleimhautkontakt (Auge) mit dem Pruefmuster unbedingth zu vermeiden.", i.e. "Due to the pronounced irritant and caustic effect, any skin and mucous-membrane contact (eye) with the test item must be avoided." Furthermore, the authors note, "...jeglicher Haut- und Schleimhautkontakt (Auge) ist unbedingt zu vermeiden.", i.e. "any contact with skin or mucous membranes (eye) should be avoided at all costs". Under the conditions of the study, the test item is therefore considered to be a strong skin irritant and skin corrosive.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
other:
Justification for type of information:
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.2 (as amended by Commission Regulation (EU) 2016/863) the in vitro eye irritation study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (eq. or similar to OECD TG 405) eye irritation study is available and indicates that the substance causes serious eye damage (category 1) and a definitive conclusion on the classification can be made. Additionally, an existing skin irritation study (eq. or similar to OECD 404) is available and indicates that the substance is skin corrosive, which leads to a classification of serious eye damage (category 1). Furthermore, in accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI the weight of evidence indicates that the substance is skin and eye corrosive and therefore in vitro testing may be omitted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Conclusions:
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.2 (as amended by Commission Regulation (EU) 2016/863) the in vitro eye irritation study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (eq. or similar to OECD TG 405) eye irritation study is available and indicates that the substance causes serious eye damage (category 1) and a definitive conclusion on the classification can be made. Additionally, an existing skin irritation study (eq. or similar to OECD 404) is available and indicates that the substance is skin corrosive, which leads to a classification of serious eye damage (category 1). Furthermore, in accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI the weight of evidence indicates that the substance is skin and eye corrosive and therefore in vitro testing may be omitted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.
Executive summary:

In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.2 (as amended by Commission Regulation (EU) 2016/863) the in vitro eye irritation study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (eq. or similar to OECD TG 405) eye irritation study is available and indicates that the substance causes serious eye damage (category 1) and a definitive conclusion on the classification can be made. Additionally, an existing skin irritation study (eq. or similar to OECD 404) is available and indicates that the substance is skin corrosive, which leads to a classification of serious eye damage (category 1). Furthermore, in accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI the weight of evidence indicates that the substance is skin and eye corrosive and therefore in vitro testing may be omitted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April to June 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. Applicant assessment indicates that any deviation from current guidelines would not have affected the study outcome.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: unspecified
- Weight at study initiation: 3 - 4 kg
- Housing: individually housed in rabbit cages.
- Diet: Standard mixed rabbit food, ad libitum.
- Water: Water, ad libitum
- Acclimation period: Time not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Unspecified; ambient laboratory temperature.
- Humidity (%): Unspecified; ambient laboratory humidity.
- Air changes (per hr): Unspecified.
- Photoperiod (hrs dark / hrs light): Unspecified.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg (per animal)
- Concentration (if solution): undiluted
Duration of treatment / exposure:
A quantity of 50 mg of the undiluted test material, was placed into the conjunctival sac of one eye. The other eye remained untreated.
Observation period (in vivo):
Ocular assessment was conducted daily over the following 7 days.
Number of animals or in vitro replicates:
2 (1 male and 1 female).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Unspecified; applicant assessment: assumed none.

SCORING SYSTEM:
The ocular reaction was described in the report in prose at daily intervals after instillation, for the following 7 days. Applicant assessment indicates that the prose description contains sufficient detail for the results to be interpreted according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992. This scoring system is consistent with Draize scoring system. When present, corrosion and/or staining of conjunctivae, sclerae and cornea by the test item were recorded and reported.

TOOL USED TO ASSESS SCORE: Eye examinations were made manually, equipment details are unspecified. Applicant assessment indicates that no special equipment would be necessary to determine the outcome of the study (from the description, the results would have been clearly visible to the naked eye).
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 0 - 7d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: mean; n=2. Cornea totally corroded.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 0 - 6d
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Strong reddening.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Moderate reddening.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 0 - 6d
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Strong reddening.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: mean; n=2. Moderate reddening.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 0 - 7d
Max. score:
4
Remarks on result:
not measured/tested
Remarks:
Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Indication of corrosion
Remarks:
Cornea totally corroded
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Indication of corrosion
Remarks:
Cornea totally corroded
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Severe reddening
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Severe reddening
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Strong reddening
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Strong reddening
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion, thereby not having any effect on the classification of the substance.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
Iris observations not reported; Applicant assessment indicates this would have been deemed either not possible or unnecessary due to severe corneal corrosion, thereby not having any effect on the classification of the substance.
Irritant / corrosive response data:
"Total corrosion" of the cornea was noted at all observations. "Strong reddening" of the conjunctivae of treated eyes was observed immediately and for the following 6 days after treatment, although partially resolved to "moderate reddening" by the final observation. "Strong" chemosis of the conjunctivae was observed in both animals immediately after treatment, for the following 6 days, which reduced to "moderate" chemosis by the final observation. An iris score was not recorded in the study report. Applicant assessment indicates that this would not change the classification of the substance.
Other effects:
- Lesions and clinical observations: Total corrosion of the cornea; strong irritation of the conjunctiva with only partial reversal by the end of the study.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: Not applicable.
- Effects of rinsing or washing: Not applicable.
- Other observations: Not applicable.

Table 1. Individual scores and mean scores for the 7 day observation period

Organism number 1 2
Time After Treatment 0 - 6 days 7 days 0 - 6 days 7 days
CORNEA



Degree of Opacity 4 4 4 4
Mean (24 – 72 h)








Area of Cornea Involved 4 4 4 4





IRIS Not assessed Not assessed Not assessed Not assessed
Mean (24 – 72 h)








CONJUNCTIVAE



Redness 3 2 3 2
Mean (24 – 72 h)








Chemosis 4 3 4 3
Mean (24 – 72 h)








Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item is strongly irritating and corrosive to the eye.
Executive summary:

The study was performed historically to a guideline similar to OECD TG 405 and EU Method B.5 to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. Applicant assessment indicates that any deviation from the current guidelines would not have a significant effect on the study outcome. A volume of 50 mg of the test material was placed into the conjunctival sac of one eye of two rabbits. The other eye remained untreated. Assessment of ocular damage/irritation was made daily for 7 days following treatment. A single application of the test item to the non-irrigated eye of two rabbits produced immediate total corrosion of the cornea. "Strong" redness of the conjunctivae was observed in all treated eyes immediately after treatment, which persisted for 6 days. This reduced to "moderate" redness by the final (day 7) observation. "Strong" chemosis was observed in both treated eyes immediately after treatment, persisting for the following 6 days. This reduced to "moderate" chemosis by the final (day 7) observation. The study authors note "Aufgrund der stark ausgepraegten Reiz- und Aetzwirkung ist jedoch jeder Haut- und Schleimhautkontakt (Auge) mit dem Pruefmuster unbedingth zu vermeiden.", i.e. "Due to the pronounced irritant and caustic effect, any skin and mucous-membrane contact (eye) with the test item must be avoided." Furthermore, the authors note, "...jeglicher Haut- und Schleimhautkontakt (Auge) ist unbedingt zu vermeiden.", i.e. "any contact with skin or mucous membranes (eye) should be avoided at all costs". Under the conditions of this study, the test item is therefore considered to be strongly irritating and corrosive to the eye.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Justification for classification or non-classification

An in vivo skin irritation study, similar to OECD 404, performed in 1981, determined the substance to be skin corrosive (category 1). Due to the skin-corrosive nature of the substance, a classification of serious eye damage is already implied; however an in vivo eye irritation study, similar to OECD 405, performed in 1981 is already available. the study determined the substance to cause serious eye damage (category 1).