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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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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:
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