Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data (published article)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Allergic contact dermatitis from organophosphorus insecticides
Author:
Matsushita, T., Aoyama, K., Yoshimi, K., Fujita, Y., Ueda, A.
Year:
1985
Bibliographic source:
Industrial Health, 23, 145-153

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Maximisation
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Published literature study; performed prior to the adoption of OECD TG 429

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Fenitrothion: no additional details reported

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
5%
Day(s)/duration:
Not reported
Adequacy of induction:
not specified
Route:
other: dermal
Vehicle:
water
Concentration / amount:
25%
Day(s)/duration:
Not reported
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: dermal
Vehicle:
water
Concentration / amount:
0.5%, 5%
Day(s)/duration:
Not reported
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
0.5% (challenge), 5% (intradermal induction and challenge) or 25% (dermal induction) fenitrothion in distilled water was applied. Induction and challenge were undertaken according to the original method. Skin reactions were observed 24 and 48 hours after removal of the patch, and the results were graded using a procedure by Kligman.
Challenge controls:
No data
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not reported

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Summary of dermal reactions

Name

Challenge concentration

Response (%)

 

24h

48h

Fenitrothion

5%

70

70

 

0.5%

30

40

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on the results of this study (sensitisation of >=30% in response to an intradermal induction of >1.0%), fenitrothion is considered to be a moderate sensitiser and is classified as a skin sensitiser in Category 1B according to the CLP Regulation.
Executive summary:

The skin sensitisation potential of fenitrothion was investigated in a published guinea pig Maximisation study. Groups of guinea pigs were induced using intradermal injection of 5% fenitrothion (in distilled water) and dermal application of 25% fenitrothion. All animals were subject to dermal challenge using 0.5% and 5% fenitrothion; dermal reactions were assessed at 24 and 48 hours following the challenge application. At 24 hours, positive responses were reported for 30% of the animals exposed to 0.5% fenitrothion and 70% of the animals exposed to 5% fenitrothion. At 48 hours, positive responses were reported for 40% of the animals exposed to 0.5% fenitrothion and 70% of the animals exposed to 5% fenitrothion. The study therefore indicates that fenitrothion is a skin sensitiser and requires classification as a skin sensitiser in Category 1B according to the CLP Regulation.