Reaction mass of ethyl 2,6,6-trimethylcyclohexa-1,3-diene-1-carboxylate and ethyl 2,6,6-trimethylcyclohexa-2,4-diene-1-carboxylate and ethyl 6,6-dimethyl-2-methylenecyclohex-3-enecarboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 28, 1974-January 1975

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

No guideline available in the report as the test has been performed prior to the OECD guideline. However it conforms to the OECD 401 guideline.

Principles of method if other than guideline:

An approximation of the LD50 was obtained by administering the undiluted test substance to groups of young adult rats (two males and two females) in single dose of 1.0, 2.0, 5.0, 10.0 and 15.0 mL/kg body weight by stomach intubation.

GLP compliance:

no

Remarks:

Pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of ethyl 2,6,6-trimethylcyclohexa-1,3-diene-1-carboxylate and ethyl 2,6,6-trimethylcyclohexa-2,4-diene-1-carboxylate and ethyl 6,6-dimethyl-2-methylenecyclohex-3-enecarboxylate

EC Number:

915-634-1

Molecular formula:

C12H18O2

IUPAC Name:

Reaction mass of ethyl 2,6,6-trimethylcyclohexa-1,3-diene-1-carboxylate and ethyl 2,6,6-trimethylcyclohexa-2,4-diene-1-carboxylate and ethyl 6,6-dimethyl-2-methylenecyclohex-3-enecarboxylate

Test material form:

liquid

Details on test material:

- Description: Colourless liquid with a strong pungent odour.
- Date of reception: 28th August 1974.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Albino Wistar derived rats were used as the experimental animals.
- Source: CIVO colony (Centraal Instituut Voor Voedingsonderzoek)
- Age at study initiation: young adult
- Weight at study initiation: not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The undiluted test substance was administrated by stomach intubation to groups of young adult rats (two males and two females).

Doses:

Levels single doses: 1.0, 2.0, 5.0, 10.0 and 15.0 mL/kg body weight.

No. of animals per sex per dose:

2 animals/sex/dose

Control animals:

no

Details on study design:

Each dose was expressed in milliliter per kg in the study.

Results and discussion

Preliminary study:

No information reported.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 - < 10 mL/kg bw

Based on:

test mat.

Remarks on result:

other:

Mortality:

1/2 females at 5 mL/Kg bw (25% of mortality), 2/2 males and 2/2 females at 10 and 15 mL/Kg bw (100% of mortality).
See Table 1 below.

Clinical signs:

other: After treatment, the rats which received 10 or 15 mL/kg body weight lost consciousness and died within two to three days. One rat died at day 4. See Table 1 below.

Gross pathology:

No observed.

Any other information on results incl. tables

Table 1. Doses applied and mortality after oral administration of one dose of ethyl saffranate to groups of two male and two female rats.

Dose mL/kg body weight	Mortality
	Number		Percentage (%)
	Males	Females
1.0	0/2	0/2	0
2.0	0/2	0/2	0
5.0	0/2	1/2	25
10.0	2/2	2/2	100
15.0	2/2	2/2	100

 

From this table it is seen that LD₅₀ of ethyl saffranate is between 5.0 and 10.0 mL/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, the oral administration of ethyl safranate at various levels up to 5.0 mL/kg bw did not result in any major abnormalities. The LD50 of ethyl safranate was found to be between 5.0 and 10 mL/kg bw. However, based on female animals, it was concluded that the LD50 of ethyl safranate was 5.0 mL/kg bw, considering the relative density of the substance. Therefore, the test material is not classified according to the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In an acute oral toxicity study equivalent to the OECD test guideline No. 401, two males and two females Wistar rats per dose were given the following undiluted dose level: 1.0, 2.0, 5.0, 10.0 and 15.0 mL/kg body weight.

Mortality and clinical signs were monitored during the study.

 

Death occurred for 1/2 females at 5.0 mL/kg bw (25% of mortality) and for 2/2 males and 2/2 females at 10.0 and 15.0 mL/kg bw (100% of mortality). After treatment, the rats which received 10.0 or 15.0 mL/kg bw lost consciousness and died within two to three days. One rat died at day 4.

Oral LD₅₀ Males/Females = 5.0 mL/kg bw

The LD₅₀ of ethyl safranate was found to be between 5.0 and 10.0 mL/kg bw. Based on female animals, it was concluded that the LD₅₀ of ethyl safranate was 5.0 mL/kg bw. 

 

Therefore, the test material is not classified according to the Regulation (EC) No. 1272/2008 (CLP).