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Description of key information

Key value for chemical safety assessment

Skin sensitisation

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Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Principles of method if other than guideline:
The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pig maximization test described by Magnusson B and Kligman AM (1970) in "Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens", published by C. C. Thomas, Springfield, Illinois, U.S.A.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA was not available and adopted as an OECD guideline at the time of the current study.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Average weight at study initiation: 440 g
Route:
intradermal
Vehicle:
other: Propylene glycol
Concentration / amount:
Induction: Intradermal injection - Site 1) 0.1 mL Freund's adjuvant; site 2) 0.1 mL of a 5% solution of test substance in propylene glycol; site 3) 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% test substance solution
Challenge: After 1 week, 5% test substance in vaseline (occlusive patch for 48 h); after 14 days 25% test substance in vaseline (open application)
Route:
epicutaneous, occlusive
Vehicle:
other: Propylene glycol
Concentration / amount:
Induction: Intradermal injection - Site 1) 0.1 mL Freund's adjuvant; site 2) 0.1 mL of a 5% solution of test substance in propylene glycol; site 3) 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% test substance solution
Challenge: After 1 week, 5% test substance in vaseline (occlusive patch for 48 h); after 14 days 25% test substance in vaseline (open application)
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Test groups: 20
- Control group: 20
- Site: both sites of the spinal cord at the level of the shoulder blades

B. CHALLENGE EXPOSURE
- No. of exposures: once, one week after induction, then again 14 days later (re-challenge)
- Exposure period: after one week; exposure over the injection sites via occlusive patch for 48 h; after 14 days: open application on right flank
- Evaluation (h after challenge): Animals observed after induction and challenge, up until 72 h after re-challenge (at 14 days)
Challenge controls:
Identical to test group.
Positive control substance(s):
yes
Positive control results:
Intracutaneous application of Freund's adjuvant caused strong skin reddening, skin swelling and later necrosis and scarring
Key result
Reading:
other: After removal of the occlusive patch
Hours after challenge:
48
Group:
test group
Dose level:
5% test substance in vaseline
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No specific skin reactions
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
25% test substance in vaseline
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0% test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
No details were provided

For detailed results tables kindly refer to the attached background materials section of the IUCLID.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising.
Executive summary:

A study was conducted to evaluate the skin sensitisation potential of the test substance, C8-18 and C18-unsatd. DEA, according to OECD Guideline 406 using guinea pig maximisation assay. The procedure consisted of two parts: induction and challenge exposures. For induction, three sets of intradermal injections were given (0.1mL Freund's adjuvant; 0.1 mL of a 5% solution of test substance in propylene glycol, and 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% test substance. One week after the injections, a 5% test solution was placed on the skin over the injection sites via an occlusive patch and left for 48 h. This was followed by a re-challenge: 14 days after the cutaneous exposure, 25% test substance in vaseline was placed on the skin of the right flank (open application). Under the study conditions, test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising (Potokar, 1982).

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A study was conducted to evaluate the skin sensitisation potential of the test substance, C8-18 and C18-unsatd. DEA, according to OECD Guideline 406 using guinea pig maximisation assay. The procedure consisted of two parts: induction and challenge exposures. For induction, three sets of intradermal injections were given (0.1mL Freund's adjuvant; 0.1 mL of a 5% solution of test substance in propylene glycol, and 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% test substance. One week after the injections, a 5% test solution was placed on the skin over the injection sites via an occlusive patch and left for 48 h. This was followed by a re-challenge: 14 days after the cutaneous exposure, 25% test substance in vaseline was placed on the skin of the right flank (open application). Under the study conditions, test substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising (Potokar, 1982).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance was negative in in vivo skin sensitisation testing, therefore no classification is required for this endpoint according to CLP (EC 1272/2008) criteria.