[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane

Endpoint summary

Description of key information

The key study for skin sensitisation, conducted according to OECD 429 and in compliance with GLP, found the test material sensitising to mice (SafePharm, 2004).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: B&K Universal Ltd., Hull, Uk
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20
- Humidity (%):30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

undiluted
25% or 50% v/v in acetone/olive oil 4:1

No. of animals per dose:

16 females

Details on study design:

The mice were treated by application of 25 microlitres of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (days 0, 1, 2). A further group of 4 mice received the vehicle alone in the same manner.

Five days following the first topical application of the test material (day 5) all mice were injected via the tail vein with 250 microlitres of phosphate buffered saline containing a radiolabel. Five hours after that, all mice were killed. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group.

The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node, relative to that recorded for control nodes.
If a threefold increase compared to control values was recorded, the substance was considered a sensitiser.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Key result

Parameter:

SI

Value:

> 3

Test group / Remarks:

50% v/v

Key result

Parameter:

SI

Value:

> 3

Test group / Remarks:

100% v/v

Key result

Parameter:

SI

Value:

3

Test group / Remarks:

25% v/v

Remarks on result:

other: A stimulation index of <3 was recorded for the lowest concentration of the test material (25% v/v)

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See "Remarks"

Remarks:

Vehicle 8425.12 Dpm, 1053.1 Dpm/node 25% 7802.73 Dpm 975.3 Dpm/node (negative) 50% 30366.88 Dpm 3795.8 Dpm/node (positive) 100% 39088.36 Dpm 4886 Dpm/node (positive)

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study.

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

The test material was considered to be a sensitiser under the conditions of the test. A stimulation index of >3 was recorded for the two higher concentrations of test material (50% v/v and 100%), relative to the negative controls.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The key study for skin sensitisation, conducted according to an appropriate guideline and in compliance with GLP found the test material sensitising in a local lymph node assay (LLNA) in mice (SafePharm 2004). A stimulation index of >3 was recorded for the two higher concentrations of test material (50% v/v and 100%), relative to the negative controls. This meets the criteria for sensitiser in an LLNA.

A supporting study as also available for skin sensitisation which found the test material sensitising to guinea pig skin in a Buehler study, with 17/20 animals showing positive skin reactions at the first reading after challenge (RCC, 2003). The study was conducted according to an appropriate guideline and in compliance with GLP.

The study was conducted according to an appropriate guideline and in compliance with GLP.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

On the basis of available data, the substance is classified as a Skin Sensitiser Category 1B; 'H317: may cause an allergic skin reaction' in accordance with Regulation (EC) No. 1272/2008.