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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation, other
Remarks:
in vivo
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Study period:
Since December 12,1988 to January 5, 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Similar substance 2
IUPAC Name:
Similar substance 2

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: males : 7 weeks females: 8 weeks
- Weight at study initiation: males: 416 - 461 g females: 409 - 459 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding
- Diet : Pelleted standard Kliba 342, Batch 47188 guinea pig breeding/ maintenance diet, ad libitum.
- Water: tap water , ad libitum.
- Acclimation period: One week under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 3°C
- Humidity (%):40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark, music/tight period.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic symptoms were observed.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were observed..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article is not a sensitizer.
Executive summary:

The purpose of this skin sensitization study was to assess the allergenic potential of the substance when administered to the skin of male and female albino guinea pigs.

For this purpose the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. Ten animals (5 males, 5 females) were treated with the vehicle alone (petrolatum oil) and 20 animals (10 males, 10 females) were treated with the test article.

The study was conducted between December 5th and January 5th, 1989 at the RCC laboratories in 4452 Itingen/Switzerland.

If necessary prior to the first reading of the reactions, the skin was flushed with the vehicle or other solvents to clean the application site from staining produced by the test article, so that the reactions (erythema) were clearly visible at that time. Due to the unequivocal findings observed after the first challenge, no second challenge was performed.