Registration Dossier

Administrative data

Description of key information

There is a good quality GLP compliant acute oral toxicity study (Oral LD50 OECD401) which is reasonably modern (1987) including 5 males and 5 females.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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).
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
There is a good quality GLP compliant acute oral toxicity study (Oral LD50 OECD401) which is reasonably modern (1987) including 5 males and 5 females. This study showed no indications of toxic effect at the 5000mg/kg dose level tested.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Acute inhalation toxicity, the test substance is manufactured and sold as a 30% solution in water, inhalation exposure is not expected to be a normal route of exposure. The test substance showed very low acute toxicity via the oral route, the oral LD50 being greater than 5000ppm. Therefore acute inhalation testing has not been performed, the study is waived as not scientifically justified.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The test substance has acute oral toxicity >5000 mg/kg bodyweight, the acute dermal LD50 can therefore be assumed to also be greater than 5000mg/kg bodyweight as dermal absorption is not expected to exceed oral absorption due to it high water solubility. Therefore testing for acute dermal toxicity is waived as not scientifically justified.

Additional information

Justification for classification or non-classification