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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines, no GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test equivalent or simialr to OECD Guideline 406.

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzaldehyde
EC Number:
202-860-4
EC Name:
Benzaldehyde
Cas Number:
100-52-7
Molecular formula:
C7H6O
IUPAC Name:
benzaldehyde
Details on test material:
Batch No.: not specified
Purity: not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
None stated

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Paraffin oil (Intradermal Induction) and petrolatum (Topical Induction and Challenge)
Concentration / amount:
Intradermal Induction: 3.0%
Topical Induction: 15.0%
Challenge: 7.0%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Paraffin oil (Intradermal Induction) and petrolatum (Topical Induction and Challenge)
Concentration / amount:
Intradermal Induction: 3.0%
Topical Induction: 15.0%
Challenge: 7.0%
No. of animals per dose:
10 animals per dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 for Intradermal Induction and 10 for Topical Induction
- Exposure period: Intradermal Induction: 1 day; Topica1 Induction: 48 h, occluded
- Test groups: 10 animals per group for two groups
- Control group: yes
- Frequency of applications: once daily
- Concentrations: 3.0% (in paraffin oil) and 15.0% (in petrolatum)

B. CHALLENGE EXPOSURE
- No. of exposures: 20
- Exposure period: 24 h, occluded
- Test groups: 10 animals per group for two groups
- Control group: yes
- Concentrations: 7.0 (in petrolatum)

No additional data
Challenge controls:
None stated
Positive control substance(s):
yes
Remarks:
isoeugenol

Results and discussion

Positive control results:
The isoeugenol gave a 100% response to Guinea Pig.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: Challenge I
Hours after challenge:
48
Group:
test chemical
Dose level:
7.0% in petrolatum
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challange I. . Hours after challenge: 48.0. Group: test group. Dose level: 7.0% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
other: Challenge II
Hours after challenge:
48
Group:
test chemical
Dose level:
7.0% in petrolatum
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
One animal appeared equivocal result.
Remarks on result:
other: Reading: other: Challenge II. . Hours after challenge: 48.0. Group: test group. Dose level: 7.0% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: One animal appeared equivocal result..
Group:
negative control
Remarks on result:
other: No results provided for the negative control
Key result
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Remarks:
The isoeugenol gave a 100% response to Guinea Pig.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance appeared to be not sensitizing in Guinea pig maximization Test.
Executive summary:

This Guinea pig maximization test was conducted according to a method which similar to OECD Guideline 406.

The test substance appeared to be not sensitizing in Guinea pig maximization Test.