Registration Dossier

Administrative data

Description of key information

Not a skin irritant.
Not an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study performed in year 1959
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficient data available.
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
20 h
Observation period:
8 days
Number of animals:
2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 performed in year 1959
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficient data available.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 50 µl applied
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied. 0.05 ml
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 h
Score:
0
Max. score:
4
Reversibility:
other: no effect at all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
2
Reversibility:
other: no effect at all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no effect at all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no effect at all
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

1,4 -Butenediol has been adequately tested for its potential to cause irritation and has been determined not to be a skin or eye irritant (BASF 1959). Rabbits were treated with the undiluted test substance for 20 hours and observed for 8 days following exposure. No skin reactions were found (mean 24-48h score: 0). In the same study, 0.05 ml of 1,4 -Butenediol was applied to rabbit eyes and observations occurred for 8 days following exposure. No eye effects were noted and the mean score was 0 for cornea, iris, conjuctiva, and chemosis.

Justification for classification or non-classification

Skin irritation

Based on the results of the key study, BASF AG, 1959 (no skin reactions were observed), 1,4-butenediol would not be considered primary dermal irritant under the EU DSD criteria (EU Directive 67/548/EEC) or under the EU CLP criteria (EU Regulation 1272/2008). However, the manufacturer, through product handling knowledge, believes that B2D should be labeled Xi; R38 under the EU DSD criteria (EU Directive 67/548/EEC), and Skin Irritant, Category 2 under the EU CLP criteria (EU Regulation 1272/2008).

Eye irritation

Based on the results of the key study, BASF AG, 1959 (no effects were observed), 1,4-butenediol would not be classified as an eye irritant under the EU DSD criteria (EU Directive 67/548/EEC) or under the EU CLP criteria (EU Regulation 1272/2008).