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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 test substance was not irritating to the skin.
The test substance was corrosive to the eye.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP non-guideline, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
according to BASF-internal method
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
An application site of 2.5x2.5 was covered with the liquid.
Duration of treatment / exposure:
- back: 1, 5, 15 min and 20 h
Observation period:
8 days
Number of animals:
2 per exposure duration
Details on study design:
TEST SITE
- Area of exposure: back
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
3
Remarks on result:
other: 20 hours exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
3
Remarks on result:
other: 20 hours exposure
Irritant / corrosive response data:
- No effects observed in animals exposed for 1, 5 or 15 minutes, on the back.
- Questionable redness observed in one animal exposed for 20 h on the back.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study, non-GLP, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
according to BASF-internal standard: Two Vienna White rabbits were subjected to the test substance for 24 hours and observed for 8 days.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: saline treated eye of the same animal
Amount / concentration applied:
1 x 50 mm3 = 0.05 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
- 1 hour after exposure: slight redness, marked edema, and marked opacity was observed
- 24 hours after exposure: marked redness, marked edema, and white nictitating membrane was observed
- 8 days after exposure: slight redness, slight edema, marked opacity and slight scarring was observed
Interpretation of results:
corrosive
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

Two studies are available in which the potential to cause irritation/corrosion to the skin was evaluated. In the first study (BASF 1967) two Vienna White rabbits were treated for 1 minute, 5 minutes, 15 minutes, and 20 hours, respectively, with the test substance under occlusive conditions. Animals were observed for 8 days. No irritating effects were observed in animals exposed to 1, 5, or 15 minutes. Questionable redness was observed in one animal exposed for 20 hours. It was concluded that the test substance was not irritating to the skin. In the second study (Smyth 1962) five albino rabbits were treated 24 hours with the test substance, under open conditions. Very slight irritating effects were observed.

 

Eye irritation

Two studies are available in which the potential to cause damage to the eye was assessed. In the first study (BASF 1967) two Vienna White rabbits were subjected to the test substance (0.05 mL). Slight redness, marked edema, and marked opacity was observed 1 hour after exposure. Marked redness, marked edema, and white nictitating membrane was observed 24 hours after exposure. Eight days after exposure slight scarring was observed. In the second study (Smyth 1962) corneal injury was observed in rabbits exposed to test substance.


Justification for selection of skin irritation / corrosion endpoint:
Two skin irritation/corrosion studies are available in which the potential to cause irritation/corrosion to the skin was evaluated. The study which was performed most similar to OECD 404 study has been selected as key study.

Justification for selection of eye irritation endpoint:
Two eye irritation studies are available in which the potential to cause damage to the eye was evaluated. The study containing information about exposure duration and the amount of animals used has been selected as key study.

Effects on eye irritation: corrosive

Justification for classification or non-classification

Only questionable to very slight irritating effects were observed in animals exposed for 20 hours or higher. Based on this classification for skin irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.


 


Based on the corrosive eye effects observed 2-anilinoethanol has to be classified as Eye damage 1: H318: Causes serious eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.