Registration Dossier

Administrative data

Description of key information

Skin irritating potential of the test substance was assessed in three in vivo skin irritation studies. Slight to moderate erythema and edema were observed, not fully reversible within 8 days. Therefore, the test substance is considered to be a skin irritant.
The test substance causes severe eye damage in the available eye irritation studies in vivo.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study report, essential details given
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
unchanged solidified test substance
Duration of treatment / exposure:
single exposure
Observation period:
24 h, 8 days
Number of animals:
2
Details on study design:
SCORING SYSTEM: BASF internal standard. Scores were transfered to Draize Scoring System
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 8 d
Remarks on result:
other: after 20h exposure period
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Remarks:
after 8 d
Remarks on result:
other: after 20h exposure period
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: after 20h exposure period
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: after 20h exposure period
Irritant / corrosive response data:
No effect 1, 5 and 15 min after application
Interpretation of results:
irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study report, essential details given
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: BASF internal standard. Scores were transfered to Draize Scoring System
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24/48/72h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Staphyloma
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
ca. 3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Staphyloma
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: bleedings
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

The test item was assessed for skin irritating properties in a study performed in rabbits (BASF, 1971). After 20 hours of test substance exposure slight to moderate erythema and edema were observed and the erythema score was determined to be 2 and 3 in animal 1 and 2, respectively, not fully reversible after 8 days. Therefore, the test substance was considered to be irritating to the skin.

This evaluation is supported by further non standard skin irritation studies available. In both studies (BASF, 1973,1958) slight irritating properties to the skin of rabbits were noted. A clear evaluation with regard to classification and labelling was not possible in these supporting non standard studies.

 

Eye irritation

The test item was assessed for eye irritating properties in a non-GLP study performed in rabbits. Based on the results of the key study (BASF, 1971), the substance was considered as severely eye damaging (cornea score: 3, conjunctivae score: 2, chemosis score: 2). The results of the key study were confirmed by two supporting non-GLP studies (BASF, 1973,1958) performed in rabbits, revealing eye damaging properties of the test item.

Justification for selection of skin irritation / corrosion endpoint:
Most current in vivo study.

Justification for selection of eye irritation endpoint:
Most current in vivo study.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly corrosive

Justification for classification or non-classification

Based on the results obtained in the skin irritation/corrosion tests, the test item is classified as follows:

- R38 Irritating to the skin (according to Directive 67/548/EEC).

- H315 Causes skin irritation, Cat.2 (according to Regulation (EC) No 1272/2008).

 

Based on the results obtained in the eye irritation tests, the test item is classified as follows:

- R41 Risk of serious damage to eyes (according to Directive 67/548/EEC).

- H318 Causes serious eye damage, Cat.1 (according to Regulation (EC) No 1272/2008).