Acylation product between cocoyl chloride and aminoacids

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-01-14 to 2004-01-29

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of apple aminoacids and lauroyl chloride

EC Number:

918-984-3

Molecular formula:

not applicable

IUPAC Name:

Reaction product of apple aminoacids and lauroyl chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Constituent 3

Reference substance name:

2-methylpentane-2,4-diol

EC Number:

203-489-0

EC Name:

2-methylpentane-2,4-diol

Cas Number:

107-41-5

Molecular formula:

C6H14O2

IUPAC Name:

2-methylpentane-2,4-diol

additive 1

Reference substance name:

Tetrasodium ethylenediaminetetraacetate

EC Number:

200-573-9

EC Name:

Tetrasodium ethylenediaminetetraacetate

Cas Number:

64-02-8

Molecular formula:

C10H16N2O8.4Na

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

12 Sprague Dawle y rats (SPF Caw) originating from Elevage Janvier (53940 Le Genest-St-Isle –France), were used after a 5 to 6-day acclimatisation
period. At the beginning of the study, the animals weighted between 184g and 209g (males) and between 165g and 178g (females).

Environmental parameters for the treated group :
- temperature : between 22°C and 24°C
- relative humidity : between 30% and 51%

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals of Group 2, received an effective dose of 2000 mg/kg body weight of product, administered by force-feeding under a volume of 1.84 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg body weight of product

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

The study was carried out between 14 January 2004 and 29 January 2004, in PHYCHER Bio développement, according to the experimental protocol Ref. TAO423-version December 2000, established according to the O.E.C.D. guideline N° 423 dated 03.22.1996 concerning acute oral toxicity and the test method B.1ter of the Directive N° 96/54/EC dated 07.30.1996.
The animal control group was performed between 13 January 2004 and 28 January 2004 according to the same experimental conditions, with administration of 2000 mg/kg body weight of the control product (Distilled water), under a volume of 2 mL/kg body weight.

Statistics:

no data

Results and discussion

Preliminary study:

no preliminary study

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study

Clinical signs:

other: No clinical signs related to the administration of the test product were observed.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the product Proteol APL is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C.
Directives 67/548, 2001/59 and 99/45, the product Proteol APL must not be classified

Executive summary:

The product Proteol APL was administred to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated March 22nd, 1996 and the test method B.1ter of the Directive N°96/54/EC dated July 30th, 1996. No mortality occurred during the study. No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the product Proteol APL is higher than 2000 mg/kg body weight by oral route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the product Proteol APL must not be classified