[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 11 to 25, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: GLP study comparable to OECD TG 401.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 1500.3 - Federal Hazardous Substances Act Regulations - 16 CFR

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

environmental conditions not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol

EC Number:

943-328-8

Molecular formula:

Not applicable

IUPAC Name:

Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): MT-112

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: Animals were fasted overnight before dosing.
- Diet: Food, ad libitum
- Water: Water, ad libitum

IN-LIFE DATES: From: February 11, 1981 To: February 25, 1981.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

5000 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:
Animals were observed for mortality and clinical signs daily for 14 days. Initial and final bodyweights of animals were recorded.
- Necropsy of survivors performed: Yes; animals were subjected to gross necropsy.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 2/5 males and 1/5 female were died within 24 h of dosing.

Mortality:

- 2/5 males and 1/5 females were died within 24 h of dosing.

Clinical signs:

other: other: - Animals were depressed, ruffled and dirty within 3-4 h of dosing. - After 5-6 h several animals were severely depressed or semicomatose. - Surviving animals remained in generally poor health for 4-5 days before recovering.

Gross pathology:

- No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 Combined > 5000 mg/kg bw

Executive summary:

In an acute oral toxicity study (limit test), performed similarly to OECD Guideline No. 401, a group of Sherman-Wistar rats (5/sex) were administered a single oral dose of test material at 5000 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

 

2/5 males and 1/5 females were died within 24 h of dosing. Animals were depressed, ruffled, dirty within 3 -4 h of dosing and severely depressed or semicomatose after 5-6 h of dosing. Surviving animals remained in generally poor health for 4-5 days before recovering. All animals showed expected gains in bodyweight over the 14 -day study period. No abnormalities were noted at necropsy

 

Oral LD50 Combined > 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP). 

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.