Registration Dossier

Diss Factsheets

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid chlorides, coco
EC Number:
269-133-1
EC Name:
Acid chlorides, coco
Cas Number:
68187-89-3
Molecular formula:
variable
IUPAC Name:
dodecanoyl chloride; tetradecanoyl chloride
Constituent 2
Reference substance name:
Fatty acids, coco, chlorinated
EC Number:
307-160-3
EC Name:
Fatty acids, coco, chlorinated
Cas Number:
97553-06-5
IUPAC Name:
97553-06-5
Constituent 3
Reference substance name:
Cocoyl chloride
IUPAC Name:
Cocoyl chloride
Constituent 4
Reference substance name:
96/239
IUPAC Name:
96/239
Details on test material:
- Name of test material (as cited in study report): Kokosfettsaeurechlorid)
- Batch No.: Vers. 148/U
- Physical state: clear liquid, yellowish
- Analytical purity: 99.5 % (by GC)
- Expiration date of the lot/batch: not reported
- Stability under test conditions: confirmed by the analytical report 98L00389 as stated in the 1st amendment
- Storage condition of test material: at room temperature under exclusion of moisture and oxygen (nitrogen atmosphere)

Test animals

Species:
rat
Strain:
other: Wistar CHBB: THOM (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach (Germany)
- Age at study initiation: young adult
- Weight at study initiation: mean male 206 g (198-214 g), mean female 179 g (176-184g)
- Housing: single
- Fasting period: at least 16 h
- Diet: Kliba Labordiaet 343 (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimatization: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/ 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil DAB 10
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: substance is sensitive for hydrolysis


MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded several times in the day of administration and at least once per workday for the individual animals; weighing on d0 before administration and weekly thereafter
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities observed
Clinical signs:
other: No abnormalities observed
Gross pathology:
No abnormalities observed

Applicant's summary and conclusion

Executive summary:

The study was performed as limit test according to EU method B.1, EEC directive 92/69, and GLP requirements and is reliable without any restriction. The only test dose of 2000 mg/kg bw did not cause mortality, symptoms or necropsy findings.

Conclusion

Cocoyl chloride is practically non-toxic after oral administration.