Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guilenine 401 in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

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
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): N-alkyl "coco" diméthyl éthyl ammonium ethosulfate
- Purity >95%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69210 L'arbresle, France
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 178 +/- 7 g for males, 159 +/- 8 g for females
- Fasting period before study: 1 day
- Housing: housed in groups by sex
- Diet (e.g. ad libitum): "Rats et Souris entretien référence A04C" (U.A.R., 9160 Villemoisson-sur-Orge, Fance)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Males:
- 600 mg/kg (10 mL/kg)

Females:
- 200 mg/kg (10 ml/kg)
- 500 mg/kg (10 ml/kg)
- 750 mg/kg (15 ml/kg)
- 1,000 mg/kg (20 ml/kg)
No. of animals per sex per dose:
5 animals
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 d for females and 21 d for males
- Frequency of observations and weighing: Animals observed for clinical signs and mortality at frequent intervals on Day 1 and twice daily thereafter; body weight measured on Day 1, 8, 15 and 22.
- Necropsy of survivors performed: yes, animals were sacrificed by CO2.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 570 mg/kg bw
Based on:
act. ingr.
Mortality:
Females: No mortality observed at 200 mg/kg. 20, 80 and 100% mortality observed at 500, 750 and 1,000 mg/kg bw, respectively.
Males: 20% mortality observed at 600 mg/kg bw.
Clinical signs:
Females:
- 200 and 500 mg/kg: hypoactivity on 4/5 animals on the day of administration.
- 750 mg/kg: sedation, hypoactivity, lateral decubitus, dyspnoea, piloerection
- 1,000 mg/kg: sedation, hypoactivity, piloerection, contaminated uro-vaginal area

Males:
- 600 mg/kg: sedation, hypoactivity, piloerection, dyspnea, bloating, rhinorrhea, soft faeces.
Body weight:
Normal

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the acute oral median lethal dose (LD50) of the test substance in male/female rats was found to be >600 mg/kg bw.
Executive summary:

A study was conducted to assess the acute oral toxicity of C12-14 ADMAES (active ingredient > 95%) in Sprague-Dawley rats according to OECD guideline 401. Groups of five Sprague-Dawley rats (5/dose) received a single oral (gavage) dose of 600 mg/kg bw of the test substance. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 or 21 day observation period in females and males, respectively. Mortality was observed at 500, 750 and 1,000 mg/kg in females and 600 mg/kg in males. Under the test conditions, the acute oral median lethal dose (LD50) of the test substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw).