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:
supporting study
Study period:
1992-05-19 to 1992-08-7
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is classified ‘reliable without restriction’ because it is scientifically acceptable, was conducted according to GLP, and is well documented. The study appears to have followed OECD guideline 406 without any deviations from the guideline recommendations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): EthylfloTM 362NF Polydecene
- Substance type: Poly alpha olefin (1-decene dimer, hydrogenated)

In vivo test system

Test animals

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

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5.0% intradermal induction followed by topical induction and challenge at 10.0%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
No adverse clinical toxicity observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5.0% intradermal induction followed by topical induction and challenge at 10.0%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: No adverse clinical toxicity observed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the study, EthylfloTM 362NF Polydecene induced intradermally at 5.0% and challenged topically at 10% is not a dermal sensitizer in the guinea pig.
Executive summary:

In a dermal sensitization study using EthylfloTM362NF Polydecene in mineral oil, 10 Hartley guinea pigs/sex (test and vehicle control) and 3/sex (positive control) were tested using the Magnusson-Kligman guinea pig maximization test.

 

No signs of skin irritation, oedema, or erythema were observed in any of the male or female treatment or vehicle control group animals throughout the study period. Animals that received the positive control 1-chloro-2,4-dintrobenzene (DNCB) exhibited a positive response. No other signs of clinical toxicity were noticed following administration of the test material. The individual and group mean body weights for both male and female guinea pigs were found to be similar to those of the vehicle controls through the study period. In this study, EthylfloTM362NF Polydecene is not a dermal sensitizer.

 

This study received a Klimisch score of 1 and is classified ‘reliable without restriction’ because it is scientifically acceptable, was conducted according to GLP, and is well documented. The study appears to have followed OECD guideline 406 without any deviations from the guideline recommendations.

 

This study will not influence the DNEL.

 

[This study was considered supporting because……………….]