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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
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

Test material

1
Chemical structure
Reference substance name:
Benzeneacetaldehyde, cyclic acetal with glycerol
EC Number:
249-934-2
EC Name:
Benzeneacetaldehyde, cyclic acetal with glycerol
Cas Number:
29895-73-6
Molecular formula:
C11H14O3
IUPAC Name:
Reaction mass of cis-2-benzyl-1,3-dioxan-5-ol and rel-[(2R,4R)-2-benzyl-1,3-dioxolan-4-yl]methanol and rel-[(2R,4S)-2-benzyl-1,3-dioxolan-4-yl]methanol and trans-2-benzyl-1,3-dioxan-5-ol
Test material form:
liquid

Test animals

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

Administration / exposure

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

Results and discussion

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.
Effect levels
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.

Applicant's summary and conclusion

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.