Amides, C12-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across based on grouping of substances (category approach)

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

Justification for type of information:

Refer to section 13 of IUCLID for details on the category justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

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 chemical

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 chemical

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, read across 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 read across substance, C8-18 and C18-unsatd. DEA, according to OECD Guideline 406 using guinea pig maximisation test. 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 read across substance in propylene glycol, and 0.1 mL of a 1:1 mix of Freund's adjuvant and 5% read across 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% read across substance in vaseline was placed on the skin of the right flank (open application). Under the study conditions, read across substance did not produce any evidence of delayed contact hypersensitivity and was therefore considered non-sensitising (Potokar, 1982).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A study was conducted to evaluate the skin sensitisation potential of the read across 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 read across substance C8-18 and C18-unsatd. DEA was negative in in vivo skin sensitisation testing, therefore no classification is required for this endpoint according to CLP (EC 1272/2008) criteria.