2-benzyl-4,4,6-trimethyl-1,3-dioxane

Endpoint summary

Description of key information

Acute oral toxicity (similar to OECD TG 401): LD50 >5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 14 March 1979 and 12 April 1979.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Reference: E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods Drugs and Cosmetics (The Association of Food and Druk Officials of the United States, 1975), pp. 17-25.

Deviations:

no

GLP compliance:

no

Remarks:

study was conducted pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: No data (suitable licensed dealer)- Age at study initiation: 6 to 8 weeks - Weight at study initiation: 200-300 gram- Fasting period before study: 18 hours- Housing: Galvanized cages with indirect bedding- Diet (e.g. ad libitum): Ad libitum - Water (e.g. ad libitum): Ad libitum- Acclimation period: 2 days ENVIRONMENTAL CONDITIONS - Temperature (°C): Temperature controlled room - Humidity (%): No information available - Air changes (per hr): No information available - Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE - No information available MAXIMUM DOSE VOLUME APPLIED: 5 g/kg bw

Doses:

5 g/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: At 1 hour, 3, 6 and 24 hours and thereafter once daily.- Necropsy of survivors performed: Yes, gross necropsy- Other examinations performed: Body weights (day 1 and day 14).

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Two animals died on Day 2 and one animal died on day 4 after administration of the test item.

Clinical signs:

In all animals moisted and matted hair was observed on the first day. Slight depression was seen in one surviving animal. In two of the three animals that died depression and severe depression was noted.

Body weight:

All surviving animals had an increased bodyweight after the observation period on day 14.

Gross pathology:

No gross changes were observed in surviving animals and the animals that died, although these were partially cannibalized.

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria

Conclusions:

Under the conditions of this test, the acute oral LD50 was determined to be >5000 mg/kg bw. Based on this result, the test material does not need be classified for acute oral toxicity in accordance with the criteria outlined in EU CLP (1272/2008/EC and its amendments).

Executive summary:

In this study (comparable to OECD TG 401), 1 group of 10 rats (5 males and 5 females) was administered the test item at a dose level of 5000 mg/kg bw. Animals were observed for 14 days. Three of the 10 test animals died during the observation period. Observed clinical signs included moisted and matted hair and slight to severe depression (including animals that died). The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

In the key study (comparable to OECD TG 401), 1 group of 10 rats (5 males and 5 females) was administered the test item at a dose level of 5000 mg/kg bw. Animals were observed for 14 days. Three of the 10 test animals died during the observation period. Observed clinical signs included moisted and matted hair and slight to severe depression (including animals that died). The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg.

Justification for classification or non-classification

Based on the result from the acute oral toxicity study, Reseda body does not need be classified for acute oral toxicity in accordance with the criteria outlined in EU CLP (1272/2008/EC and its amendments).