trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-11-27 to 2008-01-15

Reliability:

1 (reliable without restriction)

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:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline

EC Number:

255-490-0

EC Name:

trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline

Cas Number:

41672-81-5

Molecular formula:

C37H69NO5

IUPAC Name:

1-palmitoyl-4-(palmitoyloxy)-L-proline

Details on test material:

- form: powder
- batch: 0724300010
- Expiry date: 30 August 2010
- 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 after an acclimatisation period of at least five days. At the beginning of the study,
the animals of the treated group weighed between 232 g and 271 g (males) and between 200 g and
220 g (females) and were 7-8 weeks old.
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 19 °C and 22 °C
- relative humidity : between 34 % and 52 %
- lighting time: 12 hours daily

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:

semiocclusive

Vehicle:

water

Details on dermal exposure:

of 2000 mg/kg body weight of LCA07033, diluted in distilled water under a volume of 10 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 vehicle (distilled water) under
a volume of 2 mL/kg body weight.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight of LCA07033 diluted in distilled water under a volume of 10 mL/kg
body weight

No. of animals per sex per dose:

Group 1 (control): 5 male rats and 5 female rats
Group 2 (treated): 5 male rats and 5 female rats

Control animals:

yes

Details on study design:

- 2 groups of rats: 10 controls and 10 treated animals (2000mg/kg body weight)
- application, under porous gauze dressing, during 24 hours
- After 24-hour exposure period, the gauze dressings were removed, and the treated areas were rinsed with distilled water.
- The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred during the study.

Clinical signs:

other: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information No symbol and risk phrase are required. Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item LCA07033 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
LCA07033 needs not be classified. No symbol and risk phrase are required.

Executive summary:

The test item LCA07033 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. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item 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 test item LCA07033 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 LCA07033 needs not be classified. No symbol and risk phrase are required.