Fatty acids, C12-16, esters with neopentyl glycol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

09 Nov - 25 Nov 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable deviations (Analytical purity not reported)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

Analytical purity not reported

GLP compliance:

yes

Remarks:

Niedersächsisches Umweltministerium, Hannover, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol

EC Number:

284-957-1

EC Name:

Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol

Cas Number:

85005-25-0

IUPAC Name:

85005-25-0

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: clear yellow liquid
- Analytical purity: no data
- Storage condition of test material: ambient 20 ± 2 °C
- Other: density 0.91 g/mL

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF cbp)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Weight at study initiation: 209-221 g (males); 153-189 g (females)
- Fasting period before study: the animals were fasted from 16 h before until 3 – 4 h after administration of the test article.
- Housing: in groups of a maximum of 5 animals per cage in Makrolon cages type III, bedding from pure soft wood dried, freed from dust and sterilized at 180°C.
- Diet: Ssniff- R Alleindiät, pelleted, ad libitum
- Water: drinking water (drinking bottles) as for human consumption, ad libitum
- Acclimation period: 13 days (range findings); 15 days (main test)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09 Nov 1993 To: 25 Nov 1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.20 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were examined at the following post-treatment intervals: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to 14 days. Body weights were recorded immediately before treatment (day 0) and on days 7 and 14 post administration (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Preliminary study:

During a preliminary range finding test with doses of 2000 mg/kg bw administered to two females no deaths occurred.

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 study period.

Clinical signs:

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

Body weight:

No effect on body weight was noted.

Gross pathology:

Just one dose: necropsy revealed the following findings which were not considered substance-related: urinary retention in urinary bladder in 1/5 males, hyperaemia in lung in 2/5 females and hydrometra in uterus in 1/5 female.

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