2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

EC Number:

288-509-6

EC Name:

2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

Cas Number:

85736-97-6

Molecular formula:

Unspecified

IUPAC Name:

11-methyldodecyl 2-methylprop-2-enoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

BOR:WISW (SPF TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann GmbH & Co KG (D-4799 Borchen)
- Age at study initiation: 9 weeks
- Weight at study initiation: males 215.3 g (mean), females 162.1 g (mean)
- Fasting period before study: yes, overnight
- Housing: groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 d

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL7kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination twice a day, bodyweights at start and termination of teh test
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights (lung , livers, kidneys, spleens, adrenals and testes)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

act. ingr.

Mortality:

Mortality was neither observed in the experimental group nor in the controls during the observation period of 14 days.

Clinical signs:

The clinical appearance and behavior of the male and fema.le rats did not differ from the controls for the wIlole experimental period. The day of and after administration the faeces of the experimental rats were covered by a
oily film, but were of normal viscocity.

Body weight:

Body weight gain in the experimental group was comparable to the control animals.

Gross pathology:

At necropsy no substance-related signs of toxicity were found in comparison to the controls. The only observation was a similar incidence of white foci on the lung surface of the experimental and control rats.

Other findings:

It was found that except of significantly higher mean testes (p < 0.01) and adrenal (p < 0.05) weights in the male rats the experimental results did not differ from those of the controls. These differences were rather small and do not demonstrate a toxic effect of the test substance.

Any other information on results incl. tables

Tissue weight (g) of male and female rats after oral treatment with the test item

	Male rats		Female rats
	Controls	Experimental	Controls	Experimental
Lung	1.12 ± 0.09	1.07 ± 0.09	0.87 ± 0.07	0.89 ± 0.08
Liver	10.37 ± 1.65	10.15 ± 1.08	6.16 ± 0.64	6.55 ± 0.44
Kidneys	1. 76 ± 0.28	1.71 ± 0.17	1.15 ± 0.07	1.18 ± 0.06
Adrenals	0.043 ± 0.004	0.047 ± 0.006*	0.06 ± 0.01	0.06 ± 0.01
Spleen	0.57 ± 0.12	0.60 ± 0.12	0.38 ± 0.04	0.42 ± 0.07
Testes	3.19 ± 0.05	2.94 + 0.14**

 

* p <0.05

** P <0.01

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of Isotridecyl methacrylate was >5000 mg/kg bw in rat.

Executive summary:

In an acute oral toxicity study according to OECD Guideline 401, groups of fasted, 9 weeks old Wistar rats (5/sex) were given a single oral dose of Isotridecyl methacrylate at a limit dose of 5000 mg/kg bw and observed for 14 days. Untreated control animals were included. During an observation period of 14 days there was neither lethality nor toxicity in relation to the treatment of the substance. 

Oral LD50 combined >5000 mg/kg bw

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