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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
yes
Remarks:
(study report with limited information; rechallenge was conducted sytemically)
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test was available before REACh came into force, therefore no additional LLNA test was performed.

Test material

Constituent 1
Reference substance name:
Benzoic acid, C12-15-alkyl esters
EC Number:
270-112-4
EC Name:
Benzoic acid, C12-15-alkyl esters
Cas Number:
68411-27-8
IUPAC Name:
68411-27-8
Details on test material:
- Name of test material (as cited in study report): trade name
- Analytical purity: no data
- Lot/batch No.: 24,755

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 260-352 g
No further information is given in the study report.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10% (w/w) in aqueous suspension
Challengeopen allclose all
Route:
other: topical and systemic (not further specified)
Vehicle:
water
Concentration / amount:
10% (w/w) in aqueous suspension
No. of animals per dose:
12
Details on study design:
RANGE FINDING TESTS:
No information provided in the study report.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 h
- Test groups: test substance
- Control group: no data
- Site: no data
- Frequency of applications: not specified
- Duration: Days 0-21 days
- Concentrations: 10% (w/w) aqueous suspensio)

B. CHALLENGE EXPOSURE
- No. of exposures: 2 (topical and systemic)
- Day(s) of challenge: 14 days after induction (not further specified)
- Exposure period: no data
- Test groups: test substance
- Control group: no data
- Site: no data
- Concentrations: 10% (w/w) aqueous suspensio)
- Evaluation (hr after challenge): no data

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: after topical challenge
Group:
test chemical
Dose level:
10% aqueous suspension
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: other: after topical challenge. Group: test group. Dose level: 10% aqueous suspension. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
other: after systemic challenge
Group:
test chemical
Dose level:
10 % aqueous suspension
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: other: after systemic challenge. Group: test group. Dose level: 10 % aqueous suspension. No with. + reactions: 0.0. Total no. in groups: 12.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified