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

Endpoint summary

Description of key information

2 acute oral and dermal toxicity studies were performed with the registered substance.
No mortality was observed.
LD50 oral and dermal > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-12-28 to 1990-01-11

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

rats 12 months old at the beginning of the study.
5 males: 182.2+/- 4.4 g
5 females: 177. 4 +/-5.4g

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10ml/kg
- Justification for choice of vehicle:the product is a cristallin salt so the water is sufficient as vehicule



MAXIMUM DOSE VOLUME APPLIED: 2g/kg

Doses:

2g/kg

No. of animals per sex per dose:

5 females and 5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:during the 3 hours following the administration, tha animals were quasi continiously observed. during the following 14 days, a daily observation was made.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Sex:

male/female

Dose descriptor:

LDLo

Effect level:

> 2 000 mg/kg bw

Sex:

male/female

Dose descriptor:

other: NOEL acute oral systemic

Effect level:

ca. 2 000 mg/kg bw

Sex:

male/female

Dose descriptor:

other: NOEC acute oral local

Effect level:

ca. 2 000 mg/kg bw

Mortality:

no deaths were recorded

Clinical signs:

no sign evidencing any toxicity at the level of the central nervous system or neuro vegetative system was noted

Body weight:

the weight increase of male and femalae animals was normal comparable to that of animals from this strain

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions employed, the chemical failed to lead any mortality.
The autopsy of the animals at the end of the trial failed to evidence any necroscopic lesions that could be related to toxic effect of the product.
The minimal lethal dose of the product is therefore greater than 2 g/kg in the Sprague Dawley rat, when administered in a single oral dose.

Executive summary:

The substance was given in a single oral administration, at the dose of 2g/kg, to 5 male rats and 5 female rats, according to the protocol recommended by the guidelines OECD (n° 401 dated 24.02.1987).

From the results of this trial , it can be conclude that, under the experimental conditions employed, the minimal lethal dose of the substance is above 2g/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

other:

Conclusions:

Effects upon inhalation of the substance were not investigated. this is not required as acute toxic potential was investigated for two other routes (oral and dermal), the substance is non volatile (vapour pressure of 1.19x10-3 Pa) and the granulometry of the substance (only 0.2% of particles are smaller than 100micrometer as the substance is in the form of pearls) would lead to negligeable exposure of terminal airways.

Executive summary:

Effects upon inhalation of the substance were not investigated. this is not required as acute toxic potential was investigated for two other routes (oral and dermal), the substance is non volatile (vapour pressure of 1.19x10-3 Pa) and the granulometry of the substance (only 0.2% of particles are smaller than 100micrometer as the substance is in the form of pearls) would lead to negligeable exposure of terminal airways.

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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)

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

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

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Sex:

male/female

Dose descriptor:

other: NOELacute dermal systemic

Effect level:

ca. 2 000 mg/kg bw

Sex:

male/female

Dose descriptor:

LDLo

Effect level:

> 2 000 mg/kg bw

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

The registered substance is not acutely toxic by oral and dermal routes according to OECD guidelines n°401 and 402.