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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 16 (Triethyl Phosphite), 2003 Paris.
Author:
OECD
Year:
2003
Bibliographic source:
UNEP Publications
Reference Type:
study report
Title:
Unnamed
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 98.8%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor:DHPW guinea pigs
Sex:
not specified
Details on test animals and environmental conditions:
Mean weight: 327 g.
Age: 5-7 weeks.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
peanut oil
Concentration / amount:
1st: Induction 5 % intracutaneous
2nd: Induction 100 % occlusive epicutaneous
3rd: Challenge 100 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
1st: Induction 5 % intracutaneous
2nd: Induction 100 % occlusive epicutaneous
3rd: Challenge 100 % occlusive epicutaneous
No. of animals per dose:
50 animals (no further details)
Details on study design:
RANGE FINDING TESTS:
Test concentrations for the main study were determined from the results of a pre-study on the irritation threshold, performed with 50 male animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epicutaneous
- Concentrations: 5% intradermal, 100% (epicutaneous)

B. CHALLENGE EXPOSURE
- No. of exposures: 1 epicutaneous
- Concentrations: 100%

Challenge controls:
No data.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 19.0. Total no. in groups: 20.0.
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Remarks on result:
other: . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0.

Any other information on results incl. tables

19 out of 20 animals showed positive results at 48 hours after challenge with the undiluted test material. None of the negative control animals showed any positive effects.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information