Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD guideline and under GLP. No deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Trade name: ELFAN AT 84
Appearance: Fine white powder
Batch No.: 0579106472002
Chemical name: sodium cocoyl isethionate
Storage: kept at ambient temperature, in the original container.

A certificate of analysis for the test material is included in the study report.
Date: 11 Oct 1991
Batch number: 0579106472002
White powder
active matter: 82.0%

pH 10%: 5

Test animals

Species:
rat
Strain:
other: CD (remote Sprague-Dawley)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Limited, England
- Age at study initiation: 5 weeks
- Weight at study initiation: 111-132g males and 106-128 females
- Fasting period before study: approximately 18 hours
- Housing: stainless steel grid cages measuring 54 x 33 x 20 cm (Steven Clarke Fabrications Limited, Alva, Clackmannanshire, Scotland).
- Diet (e.g. ad libitum): commercially-available complete pelleted rodent diet (RM1, from Special Diets Services Limited, Witham, Essex, England) was fed without restriction
- Water (e.g. ad libitum): free access to tap water taken from the public supply in England
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 37-55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: -
- Amount of vehicle (if gavage): 20 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

DOSAGE PREPARATION:
The dosage was calculated and expressed gravimetriclly in terms of the material as received. A fresh formulation of the test material was prepared on the morning of administration and any surplus remaining after dosing was destroyed on the same day.
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: Three separate inspections were made during the first hour after dosing and two further inspections during the remainder of Day 1. From Day 2 onwards, the animals were inspected twice daily (morning and afternoon). The bodyweight of each animal was recorded on the day before dosing and on Days 1, 8 and 15. The test was terminated on the morning of Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
Not applicable

Results and discussion

Preliminary study:
A preliminary study was carried out using two groups of one male and one female rat given a single oral administration of ELFAN at dosages of 400 or 800 mg/kg bodyweight, at a volume-dosage of 20 ml/kg in purified water. There was no death.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No deaths or any other signs of toxcity were observed
Mortality:
None
Clinical signs:
None
Body weight:
No effects observed
Gross pathology:
No effects observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 is greater than 2000 mg/kg bw. At this dose level no deaths occured. The substance should not be classified for acute oral toxicity.
Executive summary:

The acute oral toxicity of ELFAN AT 84, was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg. The animals were starved overnight prior to dosing. The test material was administered at a volume-dosage of 20 ml/kg in purified water. Mortality and signs of reaction to treatment were recorded during a subsequent 14-day observation period. The animals were killed on the following day and subjected to necropsy. There was no death and no sign of reaction to treatment. All animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the conditions of this study, the LD50 of the test material was greater than 2000 mg/kg and based on these data it was not classified for acute oral toxicity.