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Toxicological information

Acute Toxicity: oral

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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

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