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Diss Factsheets

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 October 19, 1981 to December 22, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Agents & Actions 5 (2), 174-179, 1975
Version / remarks:
Maurer Th., Thomann P., Weirich E.G., Hess R.
Qualifier:
according to guideline
Guideline:
other: Contact Dermatitis 4, 321-333, 1978
Version / remarks:
Maurer Th., Thomann P., Weirich E.G., Hess R.
Qualifier:
according to guideline
Guideline:
other: Contact Dermatitis 5, 1-10, 1979
Version / remarks:
Maurer Th., Thomann P., Weirich E.G., Hess R.
Qualifier:
according to guideline
Guideline:
other: Toxicology, 15, 163-171, 1980
Version / remarks:
Maurer Th., Weirich E.G. and Hess R.
Principles of method if other than guideline:
During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of TK 12871 in 50 % propylenglycol / 50 % saline 0.9 %. One control group was treated with the vehicle alone ("negative control").
On the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and on the back, while on the following days a single intracutaneous injection was given into the back. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant.(vehicle : adjuvant = 1 : 1). During week 6 a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of TK 12871 in 50 % propylenglycol/ 50 % saline 0.9 % was administered into the skin of the left flank. During week 8 a subirritant dose (50 % TK 12871 in vaseline) of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours.
GLP compliance:
yes
Type of study:
not specified
Justification for non-LLNA method:
The guinea pig test is already available for the registration of EU. Therefore, LLNA is not conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate
EC Number:
916-914-6
Molecular formula:
C27H36ClN3O3
IUPAC Name:
Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: 390-500g
- Housing: individually in Macrolon cages, type 3
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10%
- Photoperiod: 12-hrs light cycle day

Study design: in vivo (non-LLNA)

No. of animals per dose:
Ten male and ten female

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Table 1. Incidence of positive animals per group after intradermal challenge injection

 

No. of positive animals / No. of treated animals

P

Vehicle alone

3/20

> 0.01

 

 

TK 12871

4/20

*A probability of P < 0.01 was considered to indicate a significant difference.

 

Table 2. Incidence of positive animals per group after occlusive epicutaneous application

 

No. of positive animals / No. of treated animals

P

Vehicle alone

0/20

> 0.01

TK 12871

1/20

*A probability of P < 0.01 was considered to indicate a significant difference.

 

Table 3. Challenge reactions after occlusive epicutaneous administration of the test material

Animal No.

m

3751

3752

3753

3754

3755

3756

3757

3758

3759

3560

Erythema score (Draize Score) 24 hours after removal of the dressing.

0

0

0

0

0

0

0

0

1

0

Animal No.

f

3761

3762

3763

3764

3765

3766

3767

3768

3769

3770

Erythema score (Draize Score) 24 hours after removal of the dressing.

0

0

0

0

0

0

0

0

0

0

 

Table 4. Mean Bodyweights and Standard Deviation (g)

 

Vehicle control

TK 12871

male

female

male

female

pretest

453/28

435/16

426/28

422/18

end of test

625/58

584/68

685/50

629/42

Mean body weight gain

172

149

259

206

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to Agents & Actions 5 (2), 174-179, 1975, Contact Dermatitis 4, 321-333, 1978, Contact Dermatitis 5, 1-10, 1979 and Toxicology, 15, 163-171, 1980 test method, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of TK 12871. TK 12871 was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs. Therefore, TK 12871 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the CIBA-GEIGY Study Plan for 811257 and Agents & Actions 5 (2), 174-179, 1975, Contact Dermatitis 4, 321-333, 1978, Contact Dermatitis 5, 1-10, 1979 and Toxicology, 15, 163-171, 1980.A 0.1% and 50% TK12871 was used for intradermal injection and occlusively patchedrespectively, to ten male and ten female test guinea pigs to induce sensitization. The skin sensitization reactions were scored at approximately 24 hours after patch removal. At the end of study, body weight increase was observed in all animals. Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of TK 12871. Therefore, TK 12871 was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.