p-methoxybenzyl acetate

Endpoint summary

Description of key information

The test substance was determined to be a skin sensitiser (Cat. 1B).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-02-08 to 2016-03-16

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)

Version / remarks:

2010

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Version / remarks:

2003

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA:J

Remarks:

CBA/Jcr

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ca. 9 weeks
- Weight at study initiation: 20.4-23.8 g
- Housing: 1 - 5 per cage in polycarbonate box with bedding; enrichment provided
- Diet: ad libitum, PMI Feeds Inc.™ Formuiab #5008
- Water: ad libitum, Tap water
- Acclimation period: 12 days
- Indication of any skin lesions: healthy mice were used, not further specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 53-95
- Air changes (per hr): 10+
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

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

Remarks:

or unchanged

Concentration:

25, 50 and 100 %

No. of animals per dose:

5

Details on study design:

PRE-SCREEN TESTS:
A range-finding test was not conducted

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: stimulation index > 3

TREATMENT PREPARATION AND ADMINISTRATION:
Animals from the different test groups, vehicle and positive control groups were treated with the respective preparation for 3 consecutive days. The preparations were applied to the dorsum of both ears under open application with a volume of 25 µL. Afterwards a 2 day rest period was done.

Positive control substance(s):

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

Statistics:

A one-way parametric analysis of variance (ANOVA) with Dunnetfs Multiple Comparisons Test, using GraphPad InStat for Windows (GraphPad Software, San Diego California USA) was performed on DPM counts. If Test Groups showed a Stimulation Index (SI) of > 3, the extrapolated EC3 was calculated from SI values.

Positive control results:

Two positive control animals were found dead on Day 6. All positive control survivors lost weight. Test/vehicle control ratio based on group mean DPM was 15.8 for the positive control group. The positive control item produced a stimulation index > 3, confirming animal sensitization potential.

Key result

Parameter:

EC3

Remarks:

[%]

Value:

9

Test group / Remarks:

based on low (25 %) and high concentrations (100 %)

Key result

Parameter:

EC3

Remarks:

[%]

Value:

20.4

Test group / Remarks:

based on mid (50 %) to low concentration (25 %)

Cellular proliferation data / Observations:

CELLULAR PROLIFERATION DATA
For the 25 % test substance group the mean DPM count was 4778 (±2229). For the 50 % test substance group the mean DPM count was 10600 (±5886). For the 100 % test substance group the mean DPM count was 7108 (±3344).

CLINICAL OBSERVATIONS:
In the 100 % test group 1 animal was found dead on day 6. From the survivors 4 animals treated with 50 % test substance and 1 animal treated with 100 % test substance showed a reduction of body weight.

BODY WEIGHTS
From the survivors 4 animals treated with 50 % test substance and 1 animal treated with 100 % test substance showed a reduction of body weight.

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

The test substance was determined to be skin sensitizing in a LLNA test.

Executive summary:

A study was performed to assess the skin sensitization potential of the test material in the CBA/Jcr strain mouse following topical application to the dorsal surface of the ear. The study was performed according to OECD Guideline 429 and GLP. Three groups, each of 5 animals, were treated with 50 µL (25 µL per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 25 %, 50 % or 100 %. A further group of five animals was treated with acetone/olive oil 4:1 alone (vehicle control) and another group of 5 was treated with alpha-hexylcinnamaldehyde (positive control). The resulting stimulation index was ≥ 3 in all treatment groups. Based on extrapolated EC3 values of 9.0 % and 20.4 %, the test item is considered a moderate to weak sensitizer (Cat. 1B).

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Skin sensitisation

The key study was performed to assess the skin sensitization potential of the test material in mice following topical application to the dorsal surface of the ear. The study was performed according to OECD Guideline 429 and GLP. Three groups, each of 5 animals, were treated with 50 µL (25 µL per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 25 %, 50 % or 100 %. A further group of five animals was treated with acetone/olive oil 4:1 alone (vehicle control) and another group of five was treated with alpha-hexylcinnamaldehyde (positive control). The resulting stimulation index was ≥ 3 in all treatment groups. Based on extrapolated EC3 values of 9.0 % and 20.4 %, the test item is considered a moderate to weak sensitizer (Cat. 1B).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is classified for skin sensitisation into category 1B and labeled with H317 (May cause an allergic skin reaction) according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.