acetalization product between glucose and C16-18(even numbered)- alcohol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-07-03- to 2007-11-12

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): LCE07050
- Physical state: solid , powder
- Analytical purity: 100%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components: CAS number 67762-27-0, 54549-27-8, 27836-65-3
- Lot/batch No.: T 70615
- Expiration date of the lot/batch: 07 February 2009 (re-test)

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 236 g and 258 g (males) and between 208 g and
235 g (females) and were 6-8 weeks old.
Group 1 (control): 5 male rats Rm9371 to Rm9375
and 5 female rats Rf9376 to Rf9380
Group 2 (treated): 5 male rats Rm9651 to Rm9655
and 5 female rats Rf9656 to Rf9660

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 25 °C
- relative humidity : between 43 % and 62 %
- lighting time: 12 hours daily

Administration / exposure

Type of coverage:

occlusive

Vehicle:

paraffin oil

Details on dermal exposure:

TEST SITE
-Animals from Group 2 received by topical application (10% of area body), under porous gauze dressing, an effective dose
of 2000 mg/kg body weight of LCE07050, diluted in liquid paraffin under a volume of 10 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the excess of test item was removed if necessary with a gauze.
Animals from Group 1 received in the same experimental conditions the control item (distilled water) under a volume of 2 mL/kg body weight.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Concentration (if solution): 10ml/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and
D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

other: NOELacute dermal systemic

Effect level:

ca. 2 000 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LDLo

Effect level:

> 2 000 mg/kg bw

Effect levels 4

Sex:

male/female

Dose descriptor:

other: NOEC acute dermal local

Effect level:

ca. 2 000 mg/kg bw

Mortality:

No mortality occurred during the study.

Clinical signs:

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

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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat.

Executive summary:

The test item 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 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 need not to be classified. No symbol and risk phrase are required.