Benzeneacetaldehyde, cyclic acetal with glycerol

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 401: LD50: 1993 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:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Test was done before GLP came into force.

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Body Weight: 200-250 grams
- Fasting period before study: minimum 16 hours
- Diet: ad libitum
- Water: ad libitum

Route of administration:

oral: unspecified

Vehicle:

water

Doses:

1.31, 1.63, 2.05, 2.56 ml/kg

No. of animals per sex per dose:

10 per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed 1 and 6 hours after application and thereafter daily
- Necropsy of survivors performed: yes

Preliminary study:

A preliminare acute oral toxicity study is available in which 10 male rats were dosed orally with test substance at 5000 mg/kg, all 10 rats died during the study and therefore a second study was needed.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 993 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 819 - <= 2 167

Mortality:

Dose: Mortality based on ml/kg can be converted to mg/kg bw multiplying it with 1.1586. The LD50 is 1720 ml/kg bw and in mg/kg bw 1993 mg/kg bw.
1.31 ml/kg bw: 2/10 deaths,
1.63 ml/kg bw: 4/10 deaths,
2.05 ml/kg bw: 7/10 deaths,
2.56 ml/kg bw: 9/10 deaths

Clinical signs:

Ataxia, loss of righting reflex, shallow respiration and piloerection.

Gross pathology:

No abnormaities were noted in any of the animals at necropsy.

Interpretation of results:

other: Category 4

Remarks:

according to EU CLP 1272/2008 and its amendments

Conclusions:

The acute oral toxicity test showed an LD50 of 1993 mg/kg bw. In accordance with GHS criteria the substance needs to be classified as Category 4.

Executive summary:

Acute oral toxicity: In this study, performed similar to OECD TG 401, 40 male rats (10/dose) were administered the substance at dose levels of 1.31, 1.63, 2.05, 2.56 ml/kg bw (1518 - 2966 mg/kg bw, using a density of 1.1586). At 1.31 ml/kg bw 2 of 10 animals died, at 1.63 ml/kg bw 4 of 10, at 2.05 ml/kg 7 of 10 and at 2.56 ml/kg 9 of 10 animals died. The rats showed ataxia, loss of righting reflex, shallow respiration and piloerection. No abnormalities were noted in any of the animals at necropsy. The calculated acute oral LD50 for the substance in male rats was 1993 mg/kg bw with 95% CL of 1819 -2167 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 993 mg/kg bw

Quality of whole database:

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

Additional information

Acute oral toxicity: In this study, performed similar to OECD TG 401, 40 male rats (10/dose) were administered the substance at dose levels of 1.31, 1.63, 2.05, 2.56 ml/kg bw (1518 - 2966 mg/kg bw, using a density of 1.1586). At 1.31 ml/kg bw 2 of 10 animals died, at 1.63 ml/kg bw 4 of 10, at 2.05 ml/kg 7 of 10 and at 2.56 ml/kg 9 of 10 animals died. The rats showed ataxia, loss of righting reflex, shallow respiration and piloerection. No abnormalities were noted in any of the animals at necropsy.The calculated acute oral LD50 for the substance in male rats was 1993 mg/kg bw with 95% CL of 1819 -2167 mg/kg bw.

Acute dermal toxicity: An acute dermal toxicity study is available (Moreno, 1972) in which a 24-hour test substance application resulted in an LD50 > 2000 mg/kg bw. This information results in absence of classification and labelling of the acute dermal toxicity and is therefore not summarised in a study record.

Justification for classification or non-classification

Based on the acute oral LD50 value of 1992 mg/kg bw in the acute oral toxicity study the substance has to be classified for acute oral toxicity. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and its amendments the substance needs to be classified as acute toxic by the oral route, Category 4, H302: Harmful if swallowed.