3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure observation period 7 days)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

EC Number:

214-222-2

EC Name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate

Cas Number:

1115-20-4

Molecular formula:

C10H20O4

IUPAC Name:

3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate

Details on test material:

no further details

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight at initiation: 180-208g (males), 144-170g (females)
No further details.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous suspension with 0.5% carboxymethylcellulose

Details on oral exposure:

concentration in test solution 35%; application volume 28.5 or 13.3 ml/kg bw, respectively; no data about fasting prior to application.

Doses:

4640 or 10000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations:daily
- weighing: day 0, 2, or 7
- Necropsy of survivors and rats found dead

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

8 000 mg/kg bw

Remarks on result:

other: for males and females combined

Mortality:

Data on mortality are presented in the Table below. At the high dose levels rats died within 4 h as well as one female at the low dose level. Females more susceptible than males.

Clinical signs:

other: Clinical signs in both dose groups: immediately after gavage prone and side position, apathy, atony, gasping, cyanosis; 2nd day red encrusted noses; symptoms still present after 2 days. No symptoms detected 5 days after application.

Gross pathology:

Surviving rats: darkened liver and some cases of splenomegaly.
Rats found dead: dilatation of the heart; hyperemia

Other findings:

no data

Any other information on results incl. tables

Mortality in male and female rats after gavage; observation period 7 days

Dose in mg/kg bw	Males	Females
4640	0/5	1/5
10000	3/5	4/5

Applicant's summary and conclusion

Conclusions:

The oral LD50 is 8000 mg/kg bw in male and female rats combined.

Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure observation period 7 days)

Groups of 5 male and 5 female rats were gavaged with 35% aqueous suspension at dose levels of 4640 and 10000 mg/kg bw. The post exposure observation period was 7 days. Clinical signs occurred immediately after gavage: prone and side position, apathy, atony, gasping, cyanosis, and 2nd day red encrusted noses; symptoms were still present after 2 days. No symptoms were detected 5 days after application.. Generally, females were more susceptible than males. The body weight gain was not reduced. Necropsy revealed dilatated heart and some cases of splenomegaly.

Conclusion: The oral LD50 is 8000 mg/kg bw in male and female rats combined.