Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.06.2008-17.06.2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Test material form:
solid
Details on test material:
• Sponsor’s identification: LCEO8O9O
• Container : plastic fiask (n=1)
• Quantity : 592.2 g (container + contents)
• Batch n° :0731900052
• Production date: 15 November 2007
• CASNo:
It was identified under the code number: PH-08/0228.
• Date received : 22 May 2008
• Form: granular
• Colour : white
• Storage : room temperature
• Re-test date: 14 November 2010
• Purity: -
Specific details on test material used for the study:
• Sponsor’s identification: LCEO8O9O
• Container : plastic fiask (n=1)
• Quantity : 592.2 g (container + contents)
• Batch n° :0731900052
• Production date: 15 November 2007
• CASNo:
It was identified under the code number: PH-08/0228.
• Date received : 22 May 2008
• Form: granular
• Colour : white
• Storage : room temperature
• Re-test date: 14 November 2010
• Purity: -

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 acclimatisation period of at least five days. At the beginning of the study,
thc animais of the treated group weighed between 216 g and 241 g (males) and between 204 g and
216 g (females) and were 7-8 weeks old.
Group 1 (control):
5 male rats and 5 female rats
Rm0722 to Rm0726 R10727 to Rf073 I
Group 2 (treate4jj
5 male rats and 5 female rats
Rm0792 to Rm0796 Rf0797 to Rf0801

Housing
During the treatment, the animais were kept in individual cage. At D3, the animais were put into their cage by 2 or 3, The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steei mesh lid. Each cage contains sawdust bedding which vas cbanged at least 2 times a week. Each cage was installcd in conventionai air conditioned animal husbandry; the environmental conditions were:
- temperature : between 19°C and 23°C
- relative hnmidity : between 41% and 69%
- lighting thne: 12 hours daily
- rate of air exchange: at Least ten changes per hour

Food and drink
Drinking watcr (tap-water ibm public distribution system) and foodstuff were supp lied freely.
Microbiological and chemicai 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:
paraffin oil
Details on dermal exposure:
Animais from Group 2 reeeived by topicai application, under porous gauze dressing, an effective dose of 2000 mglkg body weight of LCEO8O9O, previously heated at 50°C, diluted in liquid paraffin and administered under a volume of 10 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 experimental conditions the vehicle (liquid paraffm) under a volume of 2.32 mL/kg body veight.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

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:
No systemic clinical signs related to the administration of the test item were observed.
A well defined erythema was noted, on the treated area, 24 hours after the test item administration in all treated animals. These reactions were associated with a very slight oedema in four female treated animals. The treated areas have recovered a normal aspect between D3 and D6.
Body weight:
Forty eight hours after the test item administration, it was noted a very slight decrease of the body weight (-2% in the treated male rats and -4% in the treated female rats). Then the body weight evolution of the animais remained normal, similar between treated and control animals.
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 hem LCE08090 is higher than 2000 mg/kg body weight by dermal route in the rat.

According to the criteria for classjfication, 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 hem LCE08090 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.
Executive summary:

The test item LCE08090 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 well defined erythema was noted, on the treated area, 24 hours after the test item administration in all treated animals.

These reactions were associated with a very slight oedema in four female treated animals. The treated areas have reeovered a normal aspect between D3 and D6. Forty eight hours after the test item administration, it was noted a very slight decrease of the body weight (-2% in the treated male rats and -4% in the treated female rats). Then the body weight evolution of the animals remained normal, 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 LCE08090 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 LCE08090 must not be classiflied. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 finaI), the test item must net be classified in category 4. No signal word and hazard statement are required.