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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Guinea Pig Maximisation Test is available.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.5% test item in sterile water
Challenge
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.5% test item in sterile water
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction: Slight to well defined erythema (scores of 1 and 2) at the sites of intradermal injection following administration of Freund's complete adjuvant (test and control groups), the vehicle mixed with Freund's complete adjuvant (control group) and the test item mixed with Freund's complete adjuvant (test group). A very slight erythema (scores of 1) at the sites treated with the test item in the vehicle was observed. No reaction was observed at the sites treated with the vehicle alone (control group). No reaction observed at sites treated with test item at 50 % concentration and vehicle following 40 hours of topical exposure.

Other observations: Changes in body weight were generally similar in animals from both test and control groups during the study.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to CLP Regulation (EC no. 1272/2008)
Conclusions:
The test item was tested according to the GPMT (OECD 406). No animal had a reaction during challenging. The test item is not sensitising.
Executive summary:

The test item was tested according to the GPMT (OECD 406). Induction phase was 0.5 % intradermal and challenge at 50 % in water. No animal had a reaction during challenging.

The substance is classified as no-sensitizing according to the CLP Regulation (EC no. 1272/2008).