Reaction mass of Benzenepropanal, 4-ethyl-α,α-dimethyl- and 3-(2-ethylphenyl)-2,2-dimethylpropanal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 July 1980 to 6 August 1980

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:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Reaction mass of Benzenepropanal, 4-​ethyl-​α,​α-​dimethyl- and 3-(2-ethylphenyl)-2,2-dimethylpropanal

EC Number:

916-329-6

Molecular formula:

C13H18O

IUPAC Name:

Reaction mass of Benzenepropanal, 4-​ethyl-​α,​α-​dimethyl- and 3-(2-ethylphenyl)-2,2-dimethylpropanal

Test material form:

liquid

Details on test material:

As described in 1.2 of dossier

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: 8 weeks
- Weight at study initiation: 221 – 250 g
- Fasting period before study: 16 – 20 hours
- Housing: animals were housed 5 per cage in suspended wire mesh cages
- Diet: fresh Purina rat chow, ad libitum
- Water: ad libitum
- Acclimation period: at least one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed 3-4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

4 out of 10 animals exposed to 5000 mg/kg bw died.

Clinical signs:

other: Lethargy was noted in 5 animals on day 1. Oily anogenital area was noted in 5 or more animals on day 1 and 2. The survivors were normal until day 11 and 12 when piloerection was noted in several animals. Ptosis was noted in 1 animal on day 13. The survivi

Gross pathology:

- No effects were observed in the animals that were sacrificed on day 14.
- Stained brown anogenital area, congested lung, dilated heart, excess fluid in pleural cavity, stomach and intestines distended, intestines grey and/or purple and pale exudate contained in pleural cavities and pericardium were observed in animals that died.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with CLP (1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw

Executive summary:

In a GLP compliant study, performed similar to OECD TG 401, ten male Wistar rats were exposed to the test substance via oral gavage. Animals received a dose of 5000 mg/kg bw. After an observation period of 14 days animals were necropsied. 4 out of 10 ten animals exposed died. Lethargy and oily anogenital area was noted in 5 or more animals. The survivors were normal until day 11 and 12 when piloerection was noted in several animals. Ptosis was noted in 1 animal on day 13. The surviving animals were normal on day 14. No effects were observed upon necropsy in the animals that were sacrificed on day 14. Stained brown anogenital area, congested lung, dilated heart, excess fluid in pleural cavity, stomach and intestines distended, intestines grey and/or purple and pale exudate contained in pleural cavities and pericardium were observed in animals that died. The LD50 was determined to be higher than 5000 mg/kg bw.