Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No data on batch no and composition. Study according to guideline/standards (reliability score can be 1).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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 compound: Ampholak YCE
Appearance: clear yellow liquid
Date of receipt: 29 January 1987

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: no info except for young adult
- Weight at study initiation: 89 ± 6 g (males), 90 ± 2 g (females)
- Fasting period before study: overnight prior to dosing
- Housing: five per sex in grid-bottomed polypropylene cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-61
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 6 To: 20 February 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not indicated
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: no info

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

DOSAGE PREPARATION (if unusual): the test material was neutralised to a pH of 7.0 using 1.0 M citric acid and then diluted with
distilled water to give a dose volume of 20 mL/kg at a dose level of 5000 mg/kg

Doses:
5000 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:frequently after dosing and then daily; BW weekly
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
Not required

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no mortality
Mortality:
None
Clinical signs:
None
Body weight:
No treatment-related effects
Gross pathology:
No abnormalities noted
Other findings:
No

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
As the oral LD50 is in excess of 5000 mg/kg bw, no classification according to OECD-GHS is required.
Executive summary:

The toxicity of the test material was assessed following its oral administration to a group of five male and five female rats. The procedure used meets the requirements of the limit test for acute oral toxicity described by the OECD (Organisation for Economic Co-operation and Development). Following overnight fasting rats were administered the test material, by peroral injection, at a dose level of 5000 mg/kg bw. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. No effects to treatment were observed throughout the duration of the study and no abnormalities were detected at necropsy. The results of this study indicate that the test material, Ampholak YCE, has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000 mg/kg bw. No classification is needed according to GHS-OECD.