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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
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 283 to 359 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: September 22, 1993

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: distilled water
Concentration / amount:
Epidermal applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. Prior to the study the following concentrations of FAT 46014/G have been examined on separate animals (% w/v):
1, 5, 10, 20, 30, and 50 % FAT 46014/G in distilled water. 50 % in distilled water was the highest possible concentration of the test article.
Erythema reactions were observed with 10, 20, 30, and 50 % FAT 46014/G in distilled water.
Therefore the following concentrations were used:
Epidermal induction (weeks 1 to 3)
Concentration of test article: 30 %
Vehicle: distilled water
Epidermal challenge (week 5)
Concentration of test article: 5 %
Vehicle: distilled water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
Epidermal applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. Prior to the study the following concentrations of FAT 46014/G have been examined on separate animals (% w/v):
1, 5, 10, 20, 30, and 50 % FAT 46014/G in distilled water. 50 % in distilled water was the highest possible concentration of the test article.
Erythema reactions were observed with 10, 20, 30, and 50 % FAT 46014/G in distilled water.
Therefore the following concentrations were used:
Epidermal induction (weeks 1 to 3)
Concentration of test article: 30 %
Vehicle: distilled water
Epidermal challenge (week 5)
Concentration of test article: 5 %
Vehicle: distilled water
No. of animals per dose:
The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively
Details on study design:
This test consists of an induction period with three epidermal occlusive test article applications on the same skin site for 6 hours each (weeks 1 t o 3), a rest period of 13 to 15 days, followed by a challenge period with epidermal occlusive application of the test article for 6 hours (week 5 ).
For all epidermal applications in the test and control group the following self-adhesive and occlusive chamber was used:
Hill Top Chamber"11 full system: 25 mm (Hill Top Research, Inc., Cincinnati , USA)
Approximate volume applied: 0.35 ml/chamber ( fully loaded)

Control group
The control group was treated with the vehicle during the induction period . Like in the test group the maximum sub - irritant concentration of FAT 46014/G was tested during challenge in these animals.
Challenge controls:
No data
Positive control substance(s):
yes
Remarks:
potassium-dichromate

Results and discussion

Positive control results:
None

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
11
Total no. in group:
19
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 11.0. Total no. in groups: 19.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
9
Total no. in group:
19
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 9.0. Total no. in groups: 19.0.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
FAT 46014/G is, therefore, classified as a sensitiser in albino guinea pigs according to the EEC Classification criteria (Commission Directive 93/21/EEC, April 27, 1993).
Executive summary:

A key study was conducted to determine the skin sensitisation potential of FAT 46014/G (purity: 99.8 %) in guinea pigs. Test was carried out in GLP compliance and followed the OECD guideline 406.Under the experimental conditions employed, 58 and 47 % of the 19 animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.

FAT 46014/G is therefore, classified as a sensitiser in albino guinea pigs according to the EEC Classification criteria (Commission Directive 93/21/EEC, April 27, 1993).