Reaction mass of (Z)-3-(9-octadecenyloxy)propane-1,2-diol and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-di[oxy[(hydroxymethyl)-1,2-ethanediyl]] and alpha-(Z)-octadec-9-en-1-yl-omega-hydroxy-tri[oxy[(hydroxymethyl)-1,2-ethanediyl]]

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 August – 12 September 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP study conducted in compliance with OECD Guideline 406 with minor deviation: age of the animals not reported; no data on the housing conditions

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

age of the animals not reported; no data on the housing conditions

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

COFRAC Accreditation for technical ability

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The study was performed before the OECD guideline 429 was adopted.

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: CHARLES RIVER (Saint Aubin Les Elbeuf, France)
- Weight at study initiation: 333-392 g
- Housing: Individually in polypropylene cage
- Diet: Pelleted diet UAR 106 (Epinay sur Orge, France)
- Acclimation period: At least 5 days

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

Range finding tests:
- Determination of maximum non-irritating concentration: 12.5, 25, 50 and 100 % (w/v) in distilled water
- Determination of maximum irritating concentration: 12.5, 25, 50 and 100 % (w/v)

Main test:
- Intradermal induction exposure: 12.5 % (w/v) in distilled water, 12.5 % (w/v) in a mixture of 1:1 (v/v) of Freund's Complete Adjuvant (FCA) and distilled water
- Topical induction exposure: Undiluted
- Topical challenge exposure: 12.5 and 25 % (w/v) in distilled water

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

Range finding tests:
- Determination of maximum non-irritating concentration: 12.5, 25, 50 and 100 % (w/v) in distilled water
- Determination of maximum irritating concentration: 12.5, 25, 50 and 100 % (w/v)

Main test:
- Intradermal induction exposure: 12.5 % (w/v) in distilled water, 12.5 % (w/v) in a mixture of 1:1 (v/v) of Freund's Complete Adjuvant (FCA) and distilled water
- Topical induction exposure: Undiluted
- Topical challenge exposure: 12.5 and 25 % (w/v) in distilled water

No. of animals per dose:

- Range finding test: 2 or 3 animals
- Main test: 5 and 10 animals for control and treatment group, respectively

Details on study design:

RANGE FINDING TEST:
- Determination of maximum non-irritating concentration: Three guinea pigs were intradermally injected with 3 injections (0.1 mL each) of distilled water, a mixture of 1:1 (v/v) of FCA and distilled water, and distilled water diluted to 50 % in a mixture of 1:1 (v/v) of FCA and distilled water. After 7 days, the animals applied topically with 0.2 mL of 12.5, 25, 50 and 100 % w/v of test material in distilled water via occlusive patch for 24 h and evaluated for cutaneous irritation reactions at 24 and 48 h after removal of patches.
- Determination of maximum irritating concentration by intradermal injections: Two guinea pigs were intradermally injected with 4 injections (0.1 mL each) of test material at concentrations of 12.5, 25, 50 and 100 % (w/v).

MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: One
- Day of induction: Day 1
- Test group: Intradermally injected with 3 injections (0.1 mL each) of a mixture of 1:1 (v/v) of FCA and distilled water, test material diluted to 12.5 % in distilled water, test material diluted to 12.5 % in a mixture of 1:1 (v/v) of FCA and distilled water, on Day 1
- Control group: Intradermally injected with 3 injections (0.1 mL each) of distilled water, a mixture of 1:1 (v/v) of FCA and distilled water and 50 % of distilled water in a mixture of 1:1 (v/v) of FCA and distilled water, on Day 1
- Site: Both sides of the spinal column, at the shoulder level

B. INDUCTION EXPOSURE: TOPICAL
- No. of exposures: One
- Day of induction: Day 9
- Exposure period: 48 h
- Test group: Filter paper patch (2 x 4 cm) saturated with 0.5 mL of the undiluted test material applied topically via occlusive patch
- Control group: Filter paper patch (2 x 4 cm) saturated with 0.5 mL of distilled water applied topically via occlusive patch
- Site: Same intradermally injected area
- Frequency of applications: Single application

C. CHALLENGE EXPOSURE: TOPICAL
- No. of exposures: One
- Day of challenge: Day 23
- Exposure period: 24 h
- Test and control groups: Filter paper (2 x 2 cm) patch saturated with 0.2 mL of the test material diluted to 12.5 and 25 % in distilled water topically applied to the dorso-lumbar region of each animal via occlusive patch.
- Evaluation (h after removal of challenge patch): 24 and 48 h

OTHER:
- Body weight: Animals were weighed individually on Days 1 and 25 of the study.

Challenge controls:

Filter paper (2 x 2 cm) patch saturated with 0.2 mL of the test material diluted to 12.5 and 25 % in distilled water topically applied to the dorso-lumbar region of each animal via occlusive patch.

Positive control substance(s):

yes

Remarks:

2-Mercapto Benzothiazole; 5 and 2 % in vaseline

Positive control results:

In the study EVIC-CEBA Td 044 of 21 February 1997, 2-Mercapto Benzothiazole (positive control) was found to be moderately sensitising for the guinea-pig (60 % of reactive animals) when it was used diluted to 5 and 2 % in vaseline.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

12.5 and 25 % (w/v)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

12.5 and 25 % (w/v)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

12.5 and 25 % (w/v)

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

None

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

12.5 and 25 % (w/v)

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

None

Reading:

1st reading

Group:

positive control

Dose level:

5 and 2 % (w/v)

Remarks on result:

positive indication of skin sensitisation

- Bodyweight gains of guinea pigs in the test group were comparable to those observed in the control group animals.

- General state of health of all guinea-pigs put in experimentation remained satisfactory throughout the test.

Interpretation of results:

GHS criteria not met

Conclusions:

Under these test conditions, CHIMEXANE NB - LOT M 824 is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008)

Executive summary:

In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406, 10 female Hartley guinea pigs were induced with intradermal injections (0.1 mL each) of a mixture of 1:1 (v/v) of FCA and distilled water, 12.5 % (w/v) CHIMEXANE NB - LOT M 824 in distilled water, and 12.5 % (w/v) CHIMEXANE NB - LOT M 824 in a mixture of 1:1 (v/v) of FCA and distilled water, on Day 1 on three different sites on each side of the spinal column at the shoulder level. Control group of 5 females were intradermally induced with 0.1 mL of FCA plus distilled water (1:1), distilled water and FCA plus distilled water (1:1). After 7 days, the same area was topically induced with undiluted test material via occluded filter paper patch for 48 h for the treated group. Control group was patched with filter paper saturated with distilled water. After 11 days of rest period, challenge filter paper patches of 12.5 and 25 % w/v of test material in distilled water were applied to the dorso-lumbar region of each animal via occlusive patch. The test concentrations for the main study were determined from a range-finding study using two or three animals per exposure.

 

No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. CHIMEXANE NB - LOT M 824 produced a 0 % (0/10) sensitisation rate and was considered to be a non-sensitiser to guinea pig skin. Positive control (2-Mercapto Benzothiazole; 5 and 2 % in vaseline) exhibited evidence of sensitisation.

 

Under these test conditions, CHIMEXANE NB - LOT M 824 is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406, 10 female Hartley guinea pigs were induced with intradermal injections of a mixture of 1:1 (v/v) of FCA and distilled water, 12.5 % (w/v) CHIMEXANE NB in distilled water, and 12.5 % (w/v) CHIMEXANE NB in a mixture of 1:1 (v/v) of FCA and distilled water and 7 days later by topical application of CHIMEXANE NB undiluted. They were then challenged at 12.5 and 25%.

 

No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. CHIMEXANE NB was considered to be a non-sensitiser to guinea pig skin.

Migrated from Short description of key information:
In a skin sensitisation study conducted according to OECD guideline 406, CHIMEXANE NB (CAS No 71032-90-1) was not a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Only one study available.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Under the test conditions, CHIMEXANE NB is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008).