Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Some information in this page has been claimed confidential.

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Data source

Reference
Reference Type:
other: Body responsible for the Test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (Buehler)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan albino
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: Topical
Vehicle:
corn oil
Concentration / amount:
50% (w/w)
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Challenge
Route:
other: Not reported
Vehicle:
corn oil
Concentration / amount:
25% w/w
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Challenge controls:
Concentration of test material and vehicle used for each challenge: 25% (w/w) in corn oil
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
1
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20 %
No. with + reactions:
1
Total no. in group:
10
Reading:
other: Not specified
Group:
positive control
Dose level:
Not specified
Remarks on result:
other: Positive control not specified

Any other information on results incl. tables

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

Signs of irritation during induction: Three test group animals showed slight erythema after the last topical induction application.

Evidence of sensitisation of each challenge concentration: 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item exhibited no positive results in the challenge tests at a concentration of 25 % w/w in corn oil. Therefore, the test item is not classified for skin sensitisation.
Executive summary:

The test item was assessed for skin sensitisation at 50 % w/w suspension in corn oil at induction, and 25 % w/w suspension in corn for each challenge, following the Buehler method. Three test group animals showed slight erythema after the last topical induction application. However, no positive reactions were observed in the test item group at either assessment during the challenge. The test item is therefore not classified for skin sensitisation.

The study is a GLP compliant, guideline study and is suitable for assessment of this endpoint with restrictions.