Cyclohexyl methacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexyl methacrylate

EC Number:

202-943-5

EC Name:

Cyclohexyl methacrylate

Cas Number:

101-43-9

Molecular formula:

C10H16O2

IUPAC Name:

cyclohexyl 2-methylprop-2-enoate

Specific details on test material used for the study:

- Lot/batch No.: CHMA Verkaufstank 14 v.23.02.2010 PBG-Charge 010117eda0

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld (Germany)
- Age at study initiation: young adult animals ( male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: animals of comparable weight ( +/- 20 % of the mean weight)
- Housing: single housing
- Diet: ad libitum ( VRF1(P); SDS Special Diets Services, Altrip, Germany)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10 %
- Type of wrap if used: semi occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Systemic effects: No systemic clinical signs were observed during clinical examination. Local effects: No local effects were observed.

Gross pathology:

No macrosopic pathologic abnomalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Any other information on results incl. tables

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	Male	Female
Administration:	1	1
No. of animals:	5	5
Mortality (animals):	No mortality	No mortality

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met