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Description of key information

FAT 41001/F showed an extreme grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.

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:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation 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.
Specific details on test material used for the study:
Test article: FAT 41001/F
Batch No.: Op.Nr.2 2
Additional specification: Cibacron Blau P-3R
Contents/Purity: ca. 80 %
Physical properties: liquid
Storage conditions: room temperature
Validity: June, 1997
Test article received: June 25, 1992
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: between 312 to 412 g
- Housing: The animal s 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 standard guinea pig pellets - NAFAG No. 845, Gossau SG
- Water (e.g. ad libitum): ad libitum, fresh water.
- Acclimation period: November 19, 1992.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3.
- Humidity (%): 30 to 70.
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Route:
intradermal
Vehicle:
other: physiological saline and adjuvant/saline mixture
Concentration / amount:
5 %
Day(s)/duration:
0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
50%
Day(s)/duration:
7 days
Adequacy of induction:
other: non-irritant substance, but skin pre-treated with 10% SLS.
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
50%
Day(s)/duration:
5 weeks
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test groups: 10 male and 10 females
Control groups: 5 males and 5 females
Details on study design:
Test procedure

Induction procedure (weeks 1 and 2):
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.

First induction week, intradermal injection
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article FAT 41001/F in physiological saline (w/v)
- test article FAT 41001/F in the adjuvant/saline mixture (w/v)

Second induction week, epidermal application
In the second week of induction FAT 41001/F was incorporated in Vaseline (w/w) and applied on a filter paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours).

Rest period
During weeks 3 and 4 no treatments were performed.

Challenge (week 5)
The animals were teste d on the flank with FAT 41001/F in Vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours).

Control group
A control l group of 10 animals (5 m/5 f) was treated d with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test t article e to check the maximum sub irritant concentration of the test article e in adjuvant treated animals.
Challenge controls:
No data
Positive control substance(s):
yes
Remarks:
Potassium dichromate
Positive control results:
Not available
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Intradermal induction - 5%, Epidermal induction - 50% and Epidermal challenge - 50%
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Intradermal induction - 5%, Epidermal induction - 50% and Epidermal challenge - 50%
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
FAT 41001/F is classified as sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
Executive summary:

A sensitization test in albino guinea pigs was performed to determine the contact allergenic potency of FAT 41001/F in albino guinea pigs. This test was based on the OECD Guideline No. 406 and GLP. In a pre-test conducted for assessment of irritation potential, no skin irritation was observed. Therefore, the application site was pretreated with 10% sodium-lauryl sulfate (open application) 24 hours prior to the epidermal induction application. The concentration of 5% was selected for induction (day 0) and 50% was selected for epidermal induction (7 days) and epidermal challenge (5 weeks). The incidence of positive animals per group, the individual challenge reactions and the evaluation of the primary skin irritation potential was carried according to grading of Magnusson and Kligman.

Under the experimental conditions employed, 100 and 90% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. No abnormality in increase of body weight was observed in test animals. According to the maximization grading FAT 41001/F showed an extreme grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A sensitization study was performed to determine the contact allergenic potency of FAT 41001/F in albino guinea pigs. This test was based on the OECD Guideline No. 406. 100 and 90 % of the animals were sensitised by FAT 41001/F under the experimental conditions employed. According to the maximisation grading FAT 41001/F showed an extreme grade of skin-sensitising (contact allergenic) potential in albino guinea pigs .


FAT 41001/F is found to be skin sensitising in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

FAT 41001/F is found to be sensitising to skin in guinea pigs.