Cyclohexyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

According to "Appraisal of the safety of chemicals in foods, drugs and cosmetics" , by the staff of the Division of Pharmacology FDA, 1959

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zucht Winkelmann (Paderborn)
- Fasting period before study: 16 hors before application
- Weight at study initiation: between 140 and 230 g
- Housing: group, 5 animals
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

10, 12.6, 15.9, 20.0 mL/kg ( 9.94, 12.14, 15.32, 19.28 g/kg)

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

12 900 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Original data: 13.41 mL/kg

Mortality:

10 mL/kg: 1 female
12.6 mL/kg: 3 male and 2 female, day 5
15.9 mL/kg: 1 male after 48 h, 3 female day 5, 1 female day 7, 1 female day 8
20.00 mL/kg: 1 male and 2 female after 24 h, 2 female after 48 h, 4 male and 1 females day 5

Clinical signs:

other: 20 mL/kg: Apathy all Doses: depression, piloerection, anomaly position, coordination disturbance, reduced grasp and extremities tone Symptoms were seen 20 min after application up to 24 hours. Normal behaviour was seen from 24 hours onwards.

Gross pathology:

In animals that were found dead inflamed mucosa of stomach and intestinal mucosa was observed. All sacrificed animals did not show any gross internal lesions.

Any other information on results incl. tables

Mortality

Dose (mL/kg)	No. of animals	Died within
		24 h	48 h	5 days	7 days	8 days	14 days
10	5 male	0/5	0/5	0/5	0/5	0/5	0/5
	5 female	0/5	0/5	1/5	1/5	1/5	1/5
12.6	5 male	0/5	0/5	3/5	3/5	3/5	3/5
	5 female	0/5	0/5	2/5	2/5	2/5	2/5
15.9	5 male	0/5	1/5	1/5	1/5	1/5	1/5
	5 female	0/5	0/5	3/5	4/5	5/5	5/5
20.0	5 male	1/5	1/5	5/5	5/5	5/5	5/5
	5 female	2/5	4/5	5/5	5/5	5/5	5/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met