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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-08-28 to 1990-09-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): WITAMOL 118
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: at temperatures below 40°C under nitrogen under a laboratory hood in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 165 - 195 g (male); 130 - 147 g (female)
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 10
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1990-08-28 To: 1990-09-13

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.06 cm³/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
no statistics performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
0/10 animals
Clinical signs:
none
Body weight:
reduced body weight gain of females in the second study week, normal body weight gain of male animals
Gross pathology:
no findings
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The LD50 of 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was greater than 2000 mg/kg bodyweight. No clinical symptoms occurred.