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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 skin irritant (OECD 404, GLP)


Not eye irritant (OECD 405, GLP)


 


The test material when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.


 


No corneal or iridial effects were noted during the study.
Minimal conjunctiva 1 irritation was noted in one treated eye one hour after treatment.
All treated eyes appeared normal 24 hours after treatment.

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:
29-12-1994
Reliability:
1 (reliable without restriction)
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
OECD Guidel ines for Testing of Chemical s No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Method B4 in Commission Directive 92/69/ EEC (which constitutes Annex V of Council Directive 67/548/ EEC)
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three New Zealand White rabbits were used for the testing.
At the start of the study the animal s weighed 2. 12 2.20 kg and were twelve to sixteen weeks old.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The amount of test substance dose was 0.5 mL per animal.
Duration of treatment / exposure:
4 hours
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours l ater, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J. H. , (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Eval uating the Toxicity of Household Substances, National Academy of Sciences, Washington D.C. p. 31 .
Number of animals:
3
Details on study design:
NA
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- no skin irritation after 4 hours
- no evidence of a corrosive effect
Other effects:
Yel 1 ow-col oured staining was noted at al l treated skin sites throughout the study. The staining did not affect evaluation of skin responses.
Very sl ight erythema was noted at one treated skin site one hour after patch removal .
No skin reactions were noted at the 24-hour observation.

No remarks

Interpretation of results:
GHS criteria not met
Conclusions:
The test material when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.
Executive summary:

The test material  when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.

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
Study period:
29-12-1994
Reliability:
1 (reliable without restriction)
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Method B5 of Commission Directive 92/69/ EEC (which constitutes Annex V of Council Directive 67/548/EEC) .
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White rabbits were used for the testing.
At the start of the study the animals weighed 2.67 2.75 kg and were approximately twelve to sixteen weeks old.
Vehicle:
unchanged (no vehicle)
Controls:
yes
no
Amount / concentration applied:
Amount of test substance: 0.1 mL
Duration of treatment / exposure:
All treated eyes appeared normal 24 hours after treatment
Observation period (in vivo):
Assessment of ocular damage/ irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment
Details on study design:
NA
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Readness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity 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:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
Minimal conjunctiva 1 irritation was noted in one treated eye one hour after treatment.
All treated eyes appeared normal 24 hours after treatment.
Other effects:
NA

No remarks

Interpretation of results:
GHS criteria not met
Conclusions:
Based on results obtained (S)-1,3,4-trihydroxybutan-2-one is not classified.
Executive summary:

Based on results obtained (S)-1,3,4-trihydroxybutan-2-one is not classified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Not skin irritant (OECD 404, GLP)


Not eye irritant (OECD 405, GLP)


 


The test material when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.


 


No corneal or iridial effects were noted during the study.
Minimal conjunctiva 1 irritation was noted in one treated eye one hour after treatment.
All treated eyes appeared normal 24 hours after treatment.