Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study already available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No dates were provided.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Please refer to "Principles of method"
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Specific details on test material used for the study:
No specific details for test material were provided.
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
No details provided.
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Back: no amount spezified
Ear: 2 mL were applied
Duration of treatment / exposure:
Back: 1, 5 and 15 min and 20 h
Ear: 20 h
Observation period:
8 days
Number of animals:
2 animals were used for 1, 5, and 15 min exposure.
Another 2 animals were used for 20 h exposure.
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2.5 on the back, outside of the ear

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: directly after exposure time was done.
Irritation parameter:
edema score
Remarks:
1, 5, 15 min and 20 h exposure
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: back
Irritation parameter:
edema score
Remarks:
1, 5, 15 min and 20 h exposure
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: back
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
probability of weak irritation
Remarks:
Application side: back
Irritation parameter:
erythema score
Remarks:
1, 5, 15 min exposure
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: back
Irritation parameter:
erythema score
Remarks:
1, 5, 15 min and 20 h exposure
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: back
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: ear
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: ear
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: ear
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Application side: ear
Irritant / corrosive response data:
After the application of the test substance for 1, 5 and 15 min to the back no effects were detected after 24 h and 8 days.
After the application of the test substance for 20 h to the back a slight redness was detected after 24 h but was not present after 8 days.
The application of the test substance to the ear for 20 h caused no detectable effects.
Other effects:
No other local or systemic effects were observed.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo study already available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967-09-26 to 1967-10-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Please refer to "Principles of method"
Principles of method if other than guideline:
No guideline was available while the study was conducted. Therefore BASF-internal standard was used.
GLP compliance:
no
Specific details on test material used for the study:
No specific details for test material were provided.
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
No details were provided.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
0.05 mL
Duration of treatment / exposure:
Eyes were not rinsed.
Observation period (in vivo):
9 days
Number of animals or in vitro replicates:
2 animals
Details on study design:
SCORING SYSTEM:
Company internal grading was used during study performance. After guidelines were implemented this internal scoring was translated into the Draize scheme.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
- Lesions and clinical observations: Secretion was obsereved for up to 48 h. Both animals developed remaining scar tissue on the eye lid of the treated eye after 72 h. After 72 h blood was detected in the eye of animal 2.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study was conducted similar to the OECD 404 guideline. The undiluted test substance was occlusively applied to the back of rabbits for 1, 5 and 15 min and 20 h. In addition it was applied to the ear for 20 h. Irritation parameters were recorded after 24 h and 8 days after administration. After 20 h exposure a slight redness was observed on the back of the animals that was reversible within 8 days. No effects were detected after any other exposure time or observation period. The test substance was concluded to be not skin irritating.

 

Eye irritation

A non-guideline study was conducted to determine the eye irritation potential of the test substance in rabbits. The undiluted test substance was applied to the right eye of 2 rabbits. The left eye was treated with saline solution as control. Observations were recorded after 1, 2, 3, 24, 48 and 72 h and on days 6 and 8 after treatment. Mean scores at 24/48/72 h were determined to be 2.0 for cornea opacity, 1.7 for conjunctivae and 0.17 for chemosis. Cornea opacity was not fully reversible within the observation time of 8 days after treatment. Therefore the test substance was concluded to cause irreversible effects to the eye.

Justification for classification or non-classification

Skin Irritation

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218. As a result the substance is considered to be not classified for skin irritation.

 

Eye irritation

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218. As a result the substance is considered to be classified for irreversible eye damage in Category 1 (H318: Causes serious eye damage).