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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline conform, airchanges per hour not mentioned

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane
EC Number:
410-560-1
EC Name:
Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane
Cas Number:
153519-44-9
Molecular formula:
C28 H28 N3 O4 + C12 H25 / C13 H27 (represents two main components)
IUPAC Name:
Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxy phenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Age at study initiation: 10weeks
- Weight at study initiation: 359 o 447 g
- Housing: 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): fresh water ad libitum
- Acclimation period: 1d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES:
Experimental starting date: February 5, 1991
Experimental termination date: March 21, 1991

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
intradermal induction: 1, 3 and 5 % in sesame oil, 0,1 ml
epidermal induction: 10% in vaseline, 0,4g paste
epidermal challenge: 3% in vaseline, 0,2 g paste
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
intradermal induction: 1, 3 and 5 % in sesame oil, 0,1 ml
epidermal induction: 10% in vaseline, 0,4g paste
epidermal challenge: 3% in vaseline, 0,2 g paste
No. of animals per dose:
10 per sex and dose
Details on study design:
RANGE FINDING TESTS: for intradermal induction, 1, 3 and 5 % in sesame oil, Since 5% TK 13340 in sesame oil could be injected and was well
tolerated, this concentration was used for the intradermal induction

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: epidermal 48h
- Test groups: 10 male and 10 female
- Control group: 10 animals
- Site: intradermal site: neck, epidermal site: neck
- Frequency of applications: induction weeks 1 and 2, challenge week 5

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24h
- Test groups: 10 male and 10 female
- Control group: 10 animals
- Site: neck
- Concentrations: 3% in vaseline, 0,2 g paste
- Evaluation (hr after challenge): after 24h

OTHER:
Challenge controls:
A control group (at least 10 animals) 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 article to check the maximum subirritant concentration
of the test article in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
potassium dichrcronate

Results and discussion

Positive control results:
Reference values with potassium dichrchromate
intradermal and epidermal induction, 1% in saline and 10 % in vaseline, respectively
epidermal first and second challenge, 0,5% in vaseline
first challenge: 2/10 24h, 1/10 48h
second challenge: 8/10 24h, 5/10 48h

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Because the simultaneously treated positive control group showed a lower incidence of positive animals than expected, a second challenge was performed to confirm the negative results in the test group. No animal reacted. The test substance is, therefore, classified as a weak sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman and classified as not-sensitizing according EU-criteria.