Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance (10 % aqueous suspension as non-irritating concentration) showed no positive reactions after topical challenge and no positive reactions after systemic challenge in the Guinea Pig Sensitisation Test (Buehler). Under the conditions of this test the test substance is not a sensitiser. This is further supported by results from insult patch test in humans, showing no irritation and no sensitizing potential for several batches of the test item

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
Study period:
16. Feb. 1979 - 27 Apr. 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
Historical study available for this endpoint so used on animal welfare grounds to avoid further testing
Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey
- Weight at study initiation: 260 -352 g
- hair was removed from back and flanks by close clipping
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation: animals were conditioned prior to use
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Test material used in 10 % gravimetric aqueous suspension.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Test material used in 10 % gravimetric aqueous suspension.
No. of animals per dose:
12
Details on study design:
RANGE FINDING TESTS: 4 animals for testing the primary irritation threshold using 50%, 25%, 10% and 5% v/v aqueous concentration; result: score 1 after 16h and 40h ; 10 % concentration was chosen as non-irritating for the main study

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 hours
- Test group: 12 animals
- Control group: -
- Site: along the dorsal midline of the back, area 3-4 cm2
- Frequency of applications: three times weekly
- Duration: 3 weeks
- Concentrations: 0.5 ml of 10% gravimetric aqueous test material; 3" x 3" gauze pad wetted with test solution

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (two applications to determine local and systemic effects
- Day(s) of challenge: two weeks after the last induction application
- Exposure period: 6 hours
- Site: along the dorsal midline of the back (for evaluation of topical effects) as well as ventrally (for evaluation of systemic effects)
- Concentrations: 0.5 ml of 10% gravimetric aqueous test material; 3" x 3" gauze pad wetted with test solution
- Evaluation (hr after challenge): 6 h und 24 h
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
6
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
no topical (Draize scale 0-4) effects: score 0 and no systemic effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 6.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no topical (Draize scale 0-4) effects: score 0 and no systemic effects.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
12
Clinical observations:
no topical (Draize scale 0-4) effects: score 0 and no systemic effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no topical (Draize scale 0-4) effects: score 0 and no systemic effects.
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance (10 % aqueous suspension as non-irritating concentration) showed no positive reactions after topical challenge and no positive reactions after systemic challenge in the Guinea Pig Sensitisation Test (Buehler). Under the conditions of this test the test substance is not a sensitiser.
Executive summary:

The study was performed to assess the skin sensitisation potential of the test material in a Guinea Pig Sensitisation Test using the Buehler method.

Twelve male guinea pigs (260 -352 g) were exposed to 9 topical, occluded applications (6 hours/day, 3 times weekly) over 21 day period and to two challenge applications 14 days later to determine local and systemic effects. A non-irritating concentration (10 % gravimetric aqueous suspension of the test material) was used. There were no positive reactions after topical challenge and no positive reactions after systemic challenge observed. Under the conditions of this test the test substance is not a sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The study was performed to assess the skin sensitisation potential of the test material in a Guinea Pig Sensitisation Test using the Buehler method. Twelve male guinea pigs (260 -352 g) were exposed to 9 topical, occluded applications (6 hours/day, 3 times weekly) over 21 day period and to two challenge applications 14 days later to determine local and systemic effects. A non-irritating concentration (10 % gravimetric aqueous suspension of the test material) was used. There were no positive reactions after topical challenge and no positive reactions after systemic challenge observed. Under the conditions of this test the test substance is not a sensitiser.

The test materials were tested in a Repeated Insult Patch Test on humans. The objective was to determine by epidermal contact the primary or cumulative irritation and/or sensitisation potential of the test materials. 53 participants, ranging in age from 18 to 70 years, both sex, who qualified for this study. 48 subjects completed this evaluation.

Induction: epicutaneous, semiocclusive application of 20% test material (24 h exposure) three times per week for a total of ten applications. Challenge: epicutaneous, semiocclusive application and site evaluation at 24 and 48 hours after application.

Results: Observations of both treated areas remained negative (no visible reactions) througout the test interval at all participants.

Under the conditions of the study, the test materials do not indicate a potential for dermal irritation and/or sensitisation:


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the substance does not require classification for skin sensitisation according to regulation (EC) 1272/2008.