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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
SKIN PHOTOALLERGENICITY
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Gunea Pig were treated with test substances and effects observed post epidermal challenge applications followed by UV-B and UV-A irradiation or followed by UV-A irradiation.
GLP compliance:
no
Type of study:
Draize test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Identity FAT 65004/F TE
Batch 15060201 (China)
Purity determined in this study
Appearance
Smell
yellowish powder, solid at 20°C
neutral
pH-Value pH-value of a soln. of 2% (w/w) = 6.90
Expiration date August 25th, 2020
Storage to be stored at room-temperature
Specific details on test material used for the study:
Test material: FAT 65004/C
Identification: Uvitex SK (DCT No. 90043)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
The test was performed on 10 male and 10 female guinea pigs per group weighing between 270 - 370 g (Approx. 10 weeks old). 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 incorporated in the Hewlett-Packard desk computer, identified with individual ear tags, kept at a constant room temperature of 20±1 C°, at a relative humidity of 55 ±5 % and on a 14 hours
light cycle day. The animals received ad libitum standard guinea pigs pellets - NAFAG No. 830, Gossau SG - supplemented with fresh carrots and fresh water.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: DAE433
Concentration / amount:
0.1 % suspension of FAT 65004/C in 80 % DAE433
Day(s)/duration:
4 Times a week for three weeks the animals were treated
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: DAE433
Concentration / amount:
0.1 % suspension of FAT 65004/C in 80 % DAE433
Day(s)/duration:
3 days
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: DAE433
Concentration / amount:
0.1 % suspension of FAT 65'004/C in 80 % DAE433
Day(s)/duration:
3
Adequacy of challenge:
not specified
No. of animals per dose:
10 male and 10 female
Details on study design:
Method:
Induction:
4 days before starting the induction, the animals were shaven on the neck and chemically depilated. During the whole induction period the animals were only shaven (Aesculap , 1/20 mm). 4 Times a week for three weeks the animals were treated by epidermal open exposure with a 0.1 % suspension of FAT 65004/C in 80 % DAE433 (0.1 ml per application; 2x2 cm application area on the animals' neck).
One hour after application the animals were irradiate for 14 minutes during the first induction week (UV-A, visible), 10 minutes during the second and third week (UV-B, UV-A, visible).
During the irradiation process the animals were immobilized in a special animal holder. In order to protect the skin surrounding of the irradiated area, this part was covered with a lightproof bandage.
24 hours after each of the first four induction applications, the skin reactions were evaluated according the Draize Scoring Scale. The reactions during the second and third induction week were not recorded.
A total of 4 adjuvant injections were made to the four corners of the application site on Monday and Wednesday of the second and third induction week (0.1 ml suspension of adjuvant complete
Freund and physiological saline per injection).

Challenge I:
12 days after the last induction irradiation, the animals were shaven on the back and the skin was chemically depilated (5 min.). 4 days later the animals were treated by epidermal open exposure for three days as during the induction period. One hour after each application the animals were irradiated for 7 minutes with a sub-erythematogenic dose of UV-B, UV-A and visible light (lamp filtered with Schott filter WG 280,3 mm).

Challenge II:
A second challenge was done after a test period of 14 days. The substance was applied again three times on the shaven skin of the animals back. The test site was irradiated after each application for 15 minutes with a sub-erythematogenic dose of UV-A and visible light (lamp filtered with Schott WG 320, 3 mm).

24 hours after each application of both challenges, the skin reactions were evaluated according the Draize Scoring Scale. Every animal with one or more score values higher at the end of the two challenge periods than that obtained at the end of the first induction week was termed positive. The number of positive animals in the test group was compared with the number of animals in the control group treated with the vehicle alone.


Challenge controls:
DAE4 33 control
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
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:
24
Group:
test group
No. with + reactions:
1
Total no. in group:
19
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

The individual erythema reactions were evaluated evaluated 24 hours after the last irradiation of either the induction or challenge I and challenge II periods.

Only one animal of the last group showed a reaction at the end of challenge period II. One animal (No. 863) died during the rest period after the induction procedure, unrelated to the treatment.

On the basis of these results, a photoallergenic potential of FAT 65 004/C in guinea-pigs can be excluded.

RESULTS:

   No of positive animals/ No of treated animals

Challenge I

DAE433 Control group

FAT65004/C

 

0/20

0/19

Challenge II

DAE433 Control group

FAT65004/C

 

0/20

1/19

Individual erythema reaction score 24 hours after the last irradiation of the induction, challenge I and challenge II:

Control Group  Animal number
DAE433 821 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840
Induction 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Challenge I 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Challenge II 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Test Group  Animal number
FAT 65004/C 861 862 863 864 865 866 867 868 869 870 871 872 873 874 875 876 877 878 879 880
Induction 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Challenge I 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Challenge II 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of these results, a photoallergenic potential of FAT 65004/C in guinea-pigs can be excluded.
Executive summary:

Under the experimental condition employed, no differences between the test group and the vehicle-treated controls were seen, after epidermal challenge applications either followed by UV-B and UV-A

irradiation or followed by UV-A irradiation alone.

FAT 65004/C was found to be devoid of a photoallergenic potential in albino guinea-pigs.