Acid chlorides, coco

Acute Toxicity: oral

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

Test material information

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.