Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one

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:

1991

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24 Feb 1987

Deviations:

yes

Remarks:

No data on analytical purity of test substance given.

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH AND SOCIAL SECURITY OF THE GOVERNMENT OF THE UNITED KINGDOM, UK

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one

EC Number:

915-610-0

Molecular formula:

C13H2O

IUPAC Name:

Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)BR

Remarks:

(VAF plus)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: approx. 100 g
- Fasting period before study: overnight
- Housing: in groups of 5, by sex, in grid bottomed cages suspended over cardboard lined excreta trays
- Diet: pelleted rat diet (SQC Rat and Mouse Maintenance Diet No.1 Expanded,Special Diets Services, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 (The temperature dropped 1°C below the protocol specified range on one occasion only and this deviation is considered not to have affected the outcome of the study.)
- Humidity (%): 47 - 65
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

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: All animals were examined approximately 30 min, 1, 2 and 4 h after dosing and daily thereafter for 14 consecutive days. All animals were weight immediately before dosing and on Day 8 and 15 thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

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:

2/5 females had to be killed in extremis 5 h 20 min after dosing

Clinical signs:

other: 2/5 females were found hypoactive and ataxic 4 h after dosing. Breathing was slow in both females and one female was laterally recumbent. 1.20 h later both animals were prostrate with eyes half closed, exhibiting slight piloerection, red/black bilateral p

Gross pathology:

There were no treatment related necropsy findings.

Any other information on results incl. tables

Table 1. Results of acute oral toxicity in rats.

Dose level (mg/kg bw)	Mortalities	Clinical signs
male
2000	0/5	5/5
female
2000	2/5 (killed in extremis)	5/5

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was found.