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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal: 5%
Topical induction: 100% (solid material, moistened with 0.9% saline).
Topical challenge: 100% (solid material, moistened with 0.9% saline).
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal: 5%
Topical induction: 100% (solid material, moistened with 0.9% saline).
Topical challenge: 100% (solid material, moistened with 0.9% saline).
No. of animals per dose:
15 animals for the test material and positive control. 5 animals for the controls.
Challenge controls:
Irritation controls were challenged with test material or positive control.
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene
Positive control results:
The positive control gave a postive response in all animals.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
6
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 6.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
5
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1%
No. with + reactions:
15
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 15.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
15
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 15.0. Total no. in groups: 15.0.
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acetone oxime was a skin sensitiser under the conditions of the test
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a reliable GPMT study the substance gave rise to a positive ie sensitising response. Skin responses were observed in 6 out of 15 test animals (40%) at 24 hours. There were no responses in the control animals. The substance gave a negative response in a Mouse Ear Swelling Test however this study was unreliable.

The positive GPMT result is consistent with that found for the read-across candidate butanone oxime (CAS 96-29-7), which also gave a positive ie sensitising response in a reliable GPMT.


Migrated from Short description of key information:
The substance is a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Two studies available on the substance however this study is the more reliable.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

On the basis of the skin sensitisation results (GPMT, 40% response following a 5% intradermal induction dose) the substance meets the criteria for classification as Skin Sens. 1B, H317.