1,3-Propanediol, 2,2-dimethyl-, C5-9 carboxylates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

31 Oct - 14 Nov 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (limited report, individual body weight records were not reported; preliminary test results not reported)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(limited report, individual body weight records were not reported; preliminary test results not reported)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Colour: light straw
- Analytical purity: 99%
- Lot/batch No.: REF 17727/6
- Storage condition of test material: at ambient temperature in the dark

Test animals

Species:

rat

Strain:

other: Alderley Park albino rat (Alpk: APfSD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Barriered Animal Breeding Unit, Alderley Park, UK
- Age at study initiation: young adult animals
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: 5 animals of the same sex per cage
- Diet: portion combined diet (PCD), Special Diet Services Limited, UK
- Water: mains, supplied by an automatic system
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12/ 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 1 mL/100 g
- Lot/batch no.: Y00790/004

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 (preliminary study)
5 (main study)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed twice on the day of dosing (Day 1) and daily until the end of the study (Day 15). Body weights were recorded on Day -1 (prior to fasting), 1, 3, between days 4 and 6, on Day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and pathology (macroscopic post mortem examination only)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the observation period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified