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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:
key study
Study period:
August 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on batch number and composition; basic data given, comparable to guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Limit test was carried out at 5000 mg/kg bw instead of 2000 mg/kg bw.
GLP compliance:
yes
Remarks:
audited in-house
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details on batch number and composition/purity
Appearance: clear colorless liquid
Date of receipt: 9 July 1984
Stored at ambient temperature

Test animals

Species:
rat
Strain:
other: HC/CFY (Remote Sprague Dawley)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill Ltd. Huntingdon, UK
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 114-132 g
- Fasting period before study: overnight prior to exposure
- Housing: in groups by sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: for a minimum of 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 64 (mean)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 3 To: 17 August 1984

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Test material applied as received.
DOSE VOLUME APPLIED: 3.76 ml/kg


Doses:
5000 mg/kg bw
No. of animals per sex per dose:
2/sex in preliminary study
5/sex in main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days (preliminary study), 14 days (main study)
- Frequency of observations and weighing: frequently on day of dosing, at least twice on following days. Weekly weighing.
- Necropsy of survivors performed: yes (main study)
Statistics:
Not needed because of limit test

Results and discussion

Preliminary study:
No mortality (0/4)
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality (0/10)
Clinical signs:
All animals (10/10): piloerection, hunched posture, abnormal gait, lethargy, decreased respiration rate, pallor of extremities,
increased salivation, diarrhoea. Recovery was complete on day 5.
Body weight:
BW gain was normal in all rats (10/10).
Gross pathology:
Terminal autopsy findings were normal.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not toxic as the acute lethal dose was > 5000 mg/kg bw
Executive summary:

The study was performed to assess the acute toxicity of the test material following a single oral administration to the Sprague-Dawley strain rat. The procedure permitted identification of the highest dose which could be administered without causing compound related mortality) . The study was performed according to OECD guideline 401. Following a preliminary test, a group of ten animals (five male and five female) was given a single, oral dose of the test material at a dose level of 5000 mg/kg bodyweight. The animals were observed for 14 days after the day of dosing and were then killed for gross pathological examination. There were no deaths. Clinical signs of toxicity noted were piloerection, hunched posture, abnormal gait, lethargy, decreased respiratory rate, pallor of extremities, increased salivation, and diarrhoea; recoevry was complete on day 5.

All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute median lethal dose (LD50) of the test material was found to be greater than 5000 mg/kg bodyweight. The test material was considered not to have significant acute toxicity and does not require classification as harmful, toxic or very toxic according to the GHS scheme.