Registration Dossier

Administrative data

Description of key information

There is a Klimisch validity 1, GLP oral LD50 study available for Coco fatty acids 2-sulfoethyl ester, sodium salt.  This study showed no adverse effects in the 5 males and 5 females dosed at 2000mg/kg.  Based on the oral LD50 being >2000mg/kg.  Dosing by the inhalation and dermal route has been waived as not scientifically justified.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD guideline and under GLP. No deviations.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
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:
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
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study is a Klimisch 1 GLP guideline study which has the test substance clearly identified with a certificate of analysis so the study is of high quality

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is a Klimisch validity 1, GLP oral LD50 study available for Coco fatty acids 2-sulfoethyl ester, sodium salt. This study showed no adverse effects in the 5 males and 5 females dosed at 2000mg/kg. Based on the oral LD50 being >2000mg/kg. Information on dermal penetration of a similar analogous substance indicates low to moderate penetration, based on this it is expected that dermal acute toxicity would be lower than oral i.e. greater than 2000mg/kg so testing was not considered scientifically justified. This was supported by the lack of any mortality at 2070 mg/kg bodyweight/day in the 28 day dermal study. Inhalation was also not seen as a likely route of exposure, as most industrial handling will be in formulations, where the low vapour pressure will minimize any potential for inhalation of vapour.

Justification for selection of acute toxicity – oral endpoint

There is a Klimisch validity 1 and GLP oral LD50 study available for Coco fatty acids 2-sulfoethyl ester, sodium salt.  This study showed no adverse effects in the 5 males and 5 females dosed at 2000mg/kg.  Based on the LD50 being >2000mg/kg and the lack of any effects Coco fatty acids 2-sulfoethyl ester, sodium salt it is not classified for acute oral toxicity based on both the EU CLP and global GHS criteria.

Justification for selection of acute toxicity – inhalation endpoint

Coco fatty acids 2-sulfoethyl ester, sodium salt has a low vapour pressure of 0.0015 Pa at 20°C so inhalation of vapour is unlikely.  The substance is supplied in both granules and powder, the powder has a relatively small particle size, but inhalation exposure is unlikely as Coco fatty acids 2-sulfoethyl ester, sodium salt it quickly added to liquid formulations and protection from dust explosion hazards will minimize the potential for inhalation.  The complete lack of oral toxicity indicates that acute inhalation toxicity is unlikely.  Therefore acute inhalation testing is waived.

Justification for selection of acute toxicity – dermal endpoint

Coco fatty acids 2-sulfoethyl ester, sodium salt had very low acute oral toxicity, with no adverse effects seen at the limit dose of 2000m/kg.  Dermal penetration testing on a similar substance Sodium lauryl isethionate which has a higher C14 content compared to the Coco fatty acids 2-sulfoethyl ester, sodium salt which is primarily C12, but does contain ca. 14% C14, showed low to moderate dermal penetrations.  Based on this it is considered unlikely that dermal absorption would exceed oral absorption.  With the lack of any adverse effect seen on the oral study at the limit dose of 2000mg/kg and the expected low absorption thought the skin it is expected that the dermal LD50 would also be >2000mg/kg.  Also in the 28 day dermal study a dose of 2070 mg/kg bodyweight/day was well tolerated with no deaths. Therefore it is considered not scientifically justified to perform such a study on animal welfare grounds.

Justification for classification or non-classification

There is a Klimisch validity 1 and GLP oral LD50 study available for Coco fatty acids 2-sulfoethyl ester, sodium salt. This study showed no adverse effects in the 5 males and 5 females dosed at 2000mg/kg. Based on the LD50 being >2000mg/kg and the lack of any effects Coco fatty acids 2-sulfoethyl ester, sodium salt it is not classified for acute oral toxicity based on both the EU CLP and global GHS criteria. Dermal acute toxicity is expected to be even lower and inhalation is not an expected route of exposure but would not be expected to more acutely toxic, inhalation would only be expected to result in some local irritation in the respiratory tract as it is an eye irritant.