Reaction mass of (E)-6-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran and (E)-7-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran and (Z)-7-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01/11/10 to 17/11/10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to international guidelines but not under GLP.

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:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Remarks:

The study has not been conducted for the purpose of REACH registration.

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (E)-6-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran and (E)-7-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran and (Z)-7-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran

EC Number:

945-481-6

IUPAC Name:

Reaction mass of (E)-6-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran and (E)-7-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran and (Z)-7-ethylidene-4a,5,6,7,8,8a-hexahydro-5,8-methano-4H-1-benzopyran

Test material form:

liquid

Details on test material:

Batch No. 60352U002
Name of the test item (as cited in study report): OXATRICYCLO
Physical state: colourless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME ADMINISTERED: 1.95 mL/kg bw (corresponding to 2000 mg/kg bw)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

- Step 1: 3 females (2000 mg/kg)
- Step 2: 3 females (2000 mg/kg)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing
Clinical signs and mortality: Animals were observed for any behavioural or toxic effects at 30 minutes, 1, 2, 3 and 4h after administration of the item and thereafter once a day until Day 14.
Bodyweight was recorded on Day-1, 4, 8 and 15 (i.e 3, 7, 14 days after administration of the test item)
- Necropsy of survivors performed: Yes; On Day 15, animals were anaesthetised with sodium pentobarbital 6% at a concentration of 1.16 mL/kg before a macroscopic examination.

Statistics:

None

Results and discussion

Preliminary study:

Not Applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed.

Mortality:

No mortality was observed.

Clinical signs:

Only slight piloerection was observed until 4h after administration of the test item. This effect was fully reversible.
No other clinical signs related to the administration of the test item were observed during the study.

Body weight:

Body weight gain of the treated animals was not affected by test item.

Gross pathology:

No macroscopic abnormalities were observed at necropsy.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The oral LD50 for ETHYLIDENE-4a,5,6,7,8,8a-HEXAHYDRO-5,8-METHANO-4H-1-BENZOPYRAN MULTICONSTITUENT is higher than 2000 mg/kg bw in female rats therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 Sprague Dawley female rats were given a single oral (gavage) dose of ETHYLIDENE-4a,5,6,7,8,8a-HEXAHYDRO-5,8-METHANO-4H-1-BENZOPYRAN MULTICONSTITUENT at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality was observed. Body weight gain of the treated animals was not affected by test item. No macroscopic abnormalities were observed at necropsy. Slight piloerection, observed 4 h after administration of the test item, was fully reversible. In this study, the oral LD50 of ETHYLIDENE-4a,5,6,7,8,8a-HEXAHYDRO-5,8-METHANO-4H-1-BENZOPYRAN MULTICONSTITUENT was considered to be higher than 2000 mg/kg bw in female rats.

Therefore, ETHYLIDENE-4a,5,6,7,8,8a-HEXAHYDRO-5,8-METHANO-4H-1-BENZOPYRAN MULTICONSTITUENT is not classified according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.