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Diss Factsheets

Administrative data

Description of key information

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:
15.May.1996-29.May.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
TEST MATERAL
Identification, reference : Matière Première Ref CS61701
Appearance: pale yellow liquid
Quantity received, packaging : 150g, 2 plastic jars
Date received: April 29, 1996
Laboratory reference: 96-1344
Analytical sheet : not supplied
Homogeneity test : not required for less than 28 days studies
Storage : at room temperature, away from the light
The test report only concerns the material to be tested
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test system
Species, strain, supplier : Albino Rat, Sprague Dawley OFA, IFFA-CREDO (69210 - L'ARBRESLE, FRANCE).
Reason for species selection : the Rat is the animal chosen by the regulatory authorities to evaluate the safety of drugs and chemicals.
Number and sex : 10, 5 males and 5 females
Age, weight: about 6 weeks, weight between 182 g and 199 g (males) and 160 g and 179g (females)
Acclimation : at least 5 days
Housing, diet: 5 animals by sex in polypropylene cages (310 x 465 x 190) in accordance with the requirements of the 86/609/EEC guideline. Complete pelleted rat maintenance diet UAR A04-10 (91360-EPINAYSURORGE, FRANCE).
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
Animals have been fasted prior to substance administration by withholding food overnight. They receive by gavage, according to the bodyweight, the product diluted in distilled water at the dose of 5000 mg/kg under a volume of 10 ml/kg.
Reason for route of administration : Oral gavage is the route of choice for estimating potential adverse effects resulting from accidental oral ingestion.
Doses:
5000 mg/kg under a volume of 10 ml/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
a clinical observation is carried out at least once a day in order to evaluate the general appearance, the behaviour and vegetative functions of the animals. An individual clinical observation is realized one hour after treatment. The continuous observations during the five following hours are renewed each following day.
body weight are taken just prior to the test animal administration (D1) and again 3, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
At termination of the 14 observation days, the reats are sacrificed after barbituric anaesthesia then autopsied. All abnormalities are recorded. No tissue is saved.
Preliminary study:
no
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
No modification in the aspect, behaviour or vegetative functions is observed in the animals, 1 hour after the treatment (table 1) or during the 5 following hours. The daily examinations which are repeated during next 13 consecutive days, fail to reveal any alteration in the general appearance and behaviour of the animals.
Body weight:
The individual growth weight of all the animals (males and females) is normal and regular.
The mean weight gain 14 days after the treatment appears satisfactory for this animal species.
Other findings:
Post mortem examinations:
The gross necropsy of the animals 14 days after the treatment does not show any visible organic or tissular lesions leading us to suspect a possible systemic toxicity of the product.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions adopted, the oral LD0 of the test material Matiere Première Ref. CS61701 in male and female Rat is higher than 5000 mg/kg.
According to the 67/548/EEC directive, the test substance is unclassified if swallowed.
Executive summary:

The single oral administration of the substance Matière Première Ref. CS61701 in the male and female Rat at the dose of 5000 mg/kg:

- does not cause any death, - has no significant toxic effect on the animals' behaviour or vegetative functions, - does not modify their weight growth, - does not cause any gross lesions visible at autopsy.

Under the experimental conditions adopted, oral LD0 of the test substance is higher than 5000 mg/kg in the Rat.

According to the 67/548/EEC directive, the test substance is unclassified if swallowed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
LD0 > 5000 mg/kg bw
Guideline study

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The study does not need to be conducted because acute toxicity data are already available for the oral route and the dermal route.

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:
8.January.2008-22.January.2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline, GLP study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
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
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)
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.).
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
Preliminary study:
no preliminary study
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
LD50 > 2000 mg/kg bw
Guideline and GLP study

Additional information

Justification for classification or non-classification

Acute toxicity oral:

According to the 67/548/EEC directive, the test substance is unclassified if swallowed.

Acute toxicity dermal:

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.