Registration Dossier

Diss Factsheets

Administrative data

Description of key information

FAT 40069/B is classified as a strong sensitizer in albino guinea pigs according to the grading of Magnusson and Kligman.

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:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
no
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:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 90'220.52
- Expiration date of the lot/batch: April 1990

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: between 328-439 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 with individual ear tags.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5 %
Day(s)/duration:
Day 1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
30 %
Day(s)/duration:
One week after epidermal injection
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
10%
Day(s)/duration:
Two weeks after epidermal injection
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 animals per group (10 males and 10 females)
Details on study design:
Test procedure:-
Induction Procedure:
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, intradermal application: Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant and saline (1:1)
- test compound FAT 4006 9/B in physiological saline
- test compound FAT 40069/B in the adjuvant saline mixture
Concentration of FAT 4006 9/B in physiological saline and adjuvant mixture: 5 %

*Second Induction, epidermal application: One week later FAT 40069/B was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours).
Dose of application: approx. 0.4 g paste of 30 % FAT 4006 9/B in vaseline.

*Challenge
Two weeks after the epidermal induction application the animals were tested on the flank with FAT 4006 9/B in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours).
Dose of application: approx. 0.2 g paste of 10 % FAT 40069/B in vaseline
The concentration of the test compound for the induction and challenge periods were determined on separate animals.
Challenge controls:
A control group was treated 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 compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
no
Positive control results:
Not investigated.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Intradermal: 5 %; epidermal: 30 % and epidermal challenge:10 %
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
Erythema and edema reactions
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Intradermal: 5 %; epidermal: 30 % and epidermal challenge:10 %
No. with + reactions:
15
Total no. in group:
20
Clinical observations:
Erythema and edema reactions
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Vehicle control
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Vehicle control
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Number of positive animals per group after epicutaneous application:

Control Group After 24 hoursPositive / Total % positive of total After 48 hoursPositive / Total % positive of total
Vehicle control 0/20 0/20
Test control 0/10 0/10
Test Group After 24 hours After 48 hours
Vehicle control 0/20 0/20
Test control 19/20 15/20
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
FAT 40069/B is classified as a strong sensitizer in guinea pigs.
Executive summary:

A study was performed to determine the sensitization of FTA 40069/B in albino guinea pigs according to the OECD guideline No. 406, adopted May 12, 1981, by the OECD Council. 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, intradermal application: Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows: Adjuvant and saline (1:1)

Test compound FAT 40069/B in physiological saline

Test compound FAT 40069/B in the adjuvant saline mixture

Concentration of FAT 40069/B in physiological saline and adjuvant mixture: 5 %.

 

Second induction, epidermal application: One week later FAT 40069/B was incorporated in Vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours).

Dose of application: approx. 0.4 g paste of 30% FAT 40069/B in Vaseline.

 

Two weeks after the epidermal induction application the animals were tested on the flank with FAT 40069/B in Vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours).

Dose of application: approx. 0.2 g paste of 10 % FAT 40069/B in Vaseline.

The concentration of the test compound for the induction and challenge periods were determined on separate animals. Under the experimental conditions employed, 75 -95 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings (Erythema and edema reactions were observed). No reactions were observed in control group.

FAT 40069/B is therefore, classified as a strong sensitizer in guinea pigs according to the grading of Magnusson and Kligman.

 

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

A study was performed in albino guinea pigs to determine the contact allergenic potency of FAT 40069/B in albino guinea pigs according to on the OECD guideline No 406, adopted May 12, 1981, by the OECD council. Under the experimental conditions employed, 75 -95 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings (Erythema and edema reactions were observed). No reactions were observed in control group. FAT 40069/B therefore is classified as a strong sensitizer to guinea pigs according to the grading of Magnusson and Kligman.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

FAT 40069/B is classified as a strong sensitizer in albino guinea pigs according to the grading of Magnusson and Kligman and hence needs tobe classified as skin sensitiser 1B according to Regulation (EC) No. 1272/2008.