reaction product of wheat aminoacids and lauryl chloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8.January.2008-22.January.2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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:

acylation product between lauroyl chloride and amino acids

EC Number:

927-837-2

Molecular formula:

Not applicable

IUPAC Name:

acylation product between lauroyl chloride and amino acids

Test material form:

liquid

Specific details on test material used for the study:

Sponsor's identification: LCE07106
Container: plastic flask (n=1)
Quantity: 184.84 g (container + contents)
Batch n° 0715200018
Production date: 01 June 2007
Date received: 21 December 2007
Form: liquid
Coulour: yellow
Storage: Room temperature
Re-test: 31 May 2009
Purity: 52.5% (dry extract)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals
Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle
– France), were used after an acclimatisation period of at least five days. At the beginning of the study,
the animals of the treated group weighed between 212 g and 234 g (males) and between 183 g and
219 g (females) and were 6-8 weeks old.
Group 1 (control): 5 male rats Rm0096 to Rm0100
and 5 female rats Rf0101 to Rf0105
Group 2 (treated): 5 male rats Rm0116 to Rm0120
and 5 female rats Rf0121 to Rf0125

Housing
During the treatment, the animals were kept in individual cage. At D3, the animals were put into their
cage by 2 or 3. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel
mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage
was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature : between 20 °C and 23 °C
- relative humidity : between 32 % and 62 %
- lighting time: 12 hours daily

Food and drink
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Administration / exposure

Type of coverage:

other: under porous gauze dressing

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Dose and administration mode
Animals from Group 2 received by topical application, under porous gauze dressing, an effective dose
of 2000 mg/kg body weight of LCE07106, under a volume of 1.81 mL/kg body weight, during 24
hours. After 24-hour exposure period, the gauze dressings were removed and the treated areas were
rinsed with distilled water.
Animals from Group 1 received in the same experimental conditions the control item (distilled water)
under a volume of 2 mL/kg body weight.

Duration of exposure:

24 h

Doses:

Group 2 (treated group): 2000 mg/kg body weight (1.81 ml/kg body weight) (LCE07106)
Group 1 (control): 2 ml/kg body waight (distilled water)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Examinations of the animals
Daily examination
Systematic examinations were carried out to identify any behavioural or toxic effects on the major
physiological functions 5 days after administration of the test solution.
This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the
observation sheet.
These observations were compared to control data.
Observations and a mortality report were then carried out every day for 14 days.

Periodical examinations
The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and
D14.
Weight changes were calculated and recorded.

Examination at the end of the test
On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to
fatal levels. Macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting
macroscopic anomalies can be removed and preserved in view to microscopic exanimations.

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:

No systemic clinical signs related to the administration of the test item were observed.
A very slight erythema was noted on the treated area in 4 female rats since D2. These reactions were
totally reversible between D3 and D4. A slight dryness was noted in the same animals at D3. These
reactions were totally reversible between D4 and D8.

Body weight:

The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

Other findings:

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:

GHS criteria not met

Conclusions:

The LD50 of the test item LCE07106 is higher than 2000 mg/kg body weight by dermal 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 test item
LCE07106 must not be classified. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not
be classified in category 4. No signal word and hazard statement are required.

Executive summary:

The test item LCE07106 was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5

females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on

the basis of the official method as defined in the O.E.C.D. guideline. n° 402 dated February 24th, 1987

and the test method B.3 of the directive. n° 92/69/EEC.

No mortality occurred during the study.

No systemic clinical signs related to the administration of the test item were observed.

A very slight erythema was noted on the treated area in 4 female rats since D2. These reactions were

totally reversible between D3 and D4. A slight dryness was noted in the same animals at D3. These

reactions were totally reversible between D4 and D8.

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 test item LCE07106 is higher than 2000 mg/kg body weight by dermal

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 test item

LCE07106 must not be classified. No symbol and risk phrase are required.

In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not

be classified in category 4. No signal word and hazard statement are required.