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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 2003-10-22 till 2004-04-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP and without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing data were considered to be sufficient for REACH registration.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technical product

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: water and Freunds Complete Adjuvant
Concentration / amount:
1st application: Induction Intradermal Injection: 5% v/v
2nd application: Induction Topical Application: 100% (0.2 ml undiluted)
3rd application: Challenge Topical Application: 100% (0.2 ml undiluted)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: water and Freunds Complete Adjuvant
Concentration / amount:
1st application: Induction Intradermal Injection: 5% v/v
2nd application: Induction Topical Application: 100% (0.2 ml undiluted)
3rd application: Challenge Topical Application: 100% (0.2 ml undiluted)
No. of animals per dose:
20 animals
Details on study design:
Injection 1: a 1:1 mixture (v/v) Freud's Complete Adjuvant (FCA) with distilled water
Injection 2: 5 % test item in distilled water
Injection 3: 5 % test item in distilled water formulated in a mixture (v/v) FCA with distilled water.
Challenge controls:
10 animals
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Results and discussion

Positive control results:
The results of using 2-mercaptobenzothiazole as positive control confirmed the skin sensitisation potential of 2-mercaptobenzothiazole and thereby the sensitivity and reliability of skin sensitisation study in guinea pig.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.2 mL of undiluted test item
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
nothing
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 undiluted test item. No with. + reactions: 0.0. Total no. in groups: 16.0. Clinical observations: nothing.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.2 mL of undiluted test item
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
nothing
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 undiluted test item. No with. + reactions: 0.0. Total no. in groups: 16.0. Clinical observations: nothing.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.2 mL of distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
nothing
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.2 mL of distilled water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
nothing
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
2-Mercaptobenzothiazole
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
12 GP showed skin response grade 1 (0,1,2,3)
Remarks on result:
positive indication of skin sensitisation
Remarks:
60% positive
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
2-Mercaptobenzthiazole
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
7 GP showed skin response grade 1 (0,1,2,3)
Remarks on result:
positive indication of skin sensitisation
Remarks:
35% positive

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was assessed for skin sensitization using the Magnusson & Kligman Maximisation test (OECD 406). Based on the results of an irritancy study, 5% concentration of FLAMMENTIN MSG in distilled water was selected for intradermal induction. 0.2 mL of undiluted technical MPAAU (FLAMMENTIN MSG) was selected for topical application during induction and challenge exposure.
The skin of the guinea pigs was observed at 24 and 48 hours after the end of the challenge exposure and the skin reactions were graded as per Magnusson and Kligman grading scale. None of the animals challenged with the test item exhibit positive skin response. No clinical signs related to treatment were observed during the study. 60% of the positive control animals exhibit positive responses at 24 hours and 35% of the positive control animals exhibit positive skin reactions at 48 hours. No systemic toxicity has been observed during the experimental period.
These data clearly demonstrate that the test item has no sensitization potential. Therefore, the test item is not to be classified for the endpoint.