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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:
From 10 August, 1994 to 8 September, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test article: FAT 11127/C
Batch No.: 9309001
Purity: ca. 80 %
Physical properties: solid
Storage conditions: room temperature
Expiry date: June 1999

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
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: 291 to 369 g
- Housing: The animals were housed individually in Macrolon cages (Type 3),
- Diet: The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG.
- Water: ad libitum
- Acclimation period: 7 days.
- Indication of any skin lesions: No

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light cycle day.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled water
Concentration / amount:
50 %
Day(s)/duration:
Weeks 1 to 3
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled water
Concentration / amount:
30 %
Day(s)/duration:
Week 5
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
- 10 male and 10 female guinea pigs in test group.
- 5 males and 5 females in the control group.
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three epidermal occlusive test application during weeks 1 to 3
- Exposure period: 3 weeks
- Test groups: Epidermal induction (weeks 1 to 3)
- Concentration of test article: 50 % in distilled water
- Control group: Distilled water
- Site: Epidermal
- Frequency of applications: once a week
- Duration: 6 hours

B. CHALLENGE EXPOSURE
- No. of exposures: One
- Exposure period: 6 Hours
- Concentration of test article: 30 % in distilled water
- Control group: Distilled water
- Site: Epidermal
- Evaluation: Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to a modified Draize scoring scale.
Challenge controls:
Distilled water
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss (Test No. 930025)

Results and discussion

Positive control results:
After 24 hrs : 4/20 animals showed a positive result.
After 48 hrs : 6/20 animals showed a positive result.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 % for induction and 30 % for challenge
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 % for induction and 30 % for challenge
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
2-Mercaptobenzothiazole puriss. induction 75 % , challenge 20 %
No. with + reactions:
4
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
2-Mercaptobenzothiazole puriss. induction 75 % , challenge 20 %
No. with + reactions:
6
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 11127/C did not show skin-sensitizing potential in albino guinea pigs.
Executive summary:

The test substance FAT 11127/C was tested for skin sensitization potential according to Buehler test as described in OECD Guideline 406. 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.

 

Epidermal induction consisted of three epidermal occlusive substance applications on the same skin site for 6 hours each (weeks 1 to 3) at concentration of 50 % test substance in distilled water, a rest period of 13 to 15 days, followed by a challenge period (at test substance concentration of 30 % in distilled water) with epidermal occlusive application of the test article for 6 hours (week 5).

 

No animal of the test group was sensitized by FAT 11127/C under the experimental conditions employed. Hence, FAT 11127/C is considered to have not shown skin-sensitizing potential in albino guinea pigs.