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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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).