Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-06-03 to 2008-06-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

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:

Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

EC Number:

500-500-3

EC Name:

Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Cas Number:

161074-67-5

Molecular formula:

Not applicable

IUPAC Name:

Acylation product between lauroyl chloride and amino acids

Test material form:

liquid

Details on test material:

• Sponsor’s identification: LCE08088
• Container : plastic flask (n=1)
• Quantity : 1056.60 g (container + contents)
• Batchn° :0801000014
• Production date: 10 January 2008
• CASNo:It was identified under the code number: Pif-08/0226.
• Date reeeived : 22 May 2008
• Form: liquid
• Colour : yellow
• Storage : room temperature
• Retest date: 09 January 2011
• Purity: 28,7% dry extract

Specific details on test material used for the study:

Sponsor's identification: LCE08088
Container: plastic flask
Quantity: 1056,60 g (container+contents)
Batch: 0801000014
Form: liquid
Colour: yellow
Storage: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle
— France), were used alter an acclinatisation period of at least five days. At the beginning of the study,
the animals of the treated group weighed between 225 g and 247 g (males) and between 197 g and
212 g (females) and were 7-8 weeks old,
Group 1 (control)
5 male rats and 5 female rats
Group 2 (treated):
5 male rats and 5 female rats


Housing
During the treatment, the animais 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 ieast 2 times a week. Each cage was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature between 19°C and 23°C
- relative humidity : between 41% and 69%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour

Food and drink
Drinking water (tap-water from public distribution systein) 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 (LE.E.B.).

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Animais from Group 2 received by topical application, under porous gauze dressing, an effective dose of 2000 mg/kg body weight of LCE08088, administered under a volume of 1.92 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed.
Animals from Group 1 received in the same experimentaI conditions the control item (liquid paraffin) under a volume of 2.32 mL/kg body weight.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

DaiIy examinination
Systematic examinations were carried out to identify any behavioural or toxic effects on the ma]or physiological functions 5 days after administration of the test solution.
This examination focuses particularly on a list of symptoms, recorded as “present” or “absent’1 on the observation sheet.
These observations were conmpared to control data.
Observations and a mortality report were then carried out every day for 14 days.

Periodical examinations
The animais 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 D 14, 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 examinations.

Results and discussion

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 systemic clinical signs related to the administration of the test item were observed. It was noted a well defined erythema, on the treated area, 24 hours after the test item administration in all treated animals, The treated areas have recovered a norm

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 test item LCE08088 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 LCE08088 must not be classifled. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required.

Executive summary:

The test item LCE08088 was applied onto the intact skin of 10 Sprague Dawley rats (5 maies and 5 femaies) 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 112e test method B. 3 ofthe directive. n° 92/69/EEC.

No mortality occured during the study.

No systemic clinical signs related to the administration of the test item were observed. It was noted a well deflned erythema, on the treated area, 24 hours afler the test hem administration in ail treated animais. The treated areas have recovered a normal aspect between D4 (maie) and D8 (female).

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 LCE08088 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 LCE08088 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 must not be classified in category 4. No signal word and hazard statement are required.