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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-08-21 to 2006-09-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1987-02-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2005-04-15
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
480-070-0
EC Name:
-
Cas Number:
85-27-8
Molecular formula:
C14H14O2
IUPAC Name:
4-(1-phenylethyl)benzene-1,3-diol
Details on test material:
- Name of test material (as cited in study report): SymWhite 377
- Chemical name: 1,3-Benzenediol, 4-(1-phenylethyl)
- Molecular formula: C14H14O2
- Molecular weight: 214.27 g/mol
- Physical state: solid
- Storage condition of test material: ambient temperature, dark, dry and in original container

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at dosing: males: 51 days; females: 62 days
- Weight at dosing: males: 227 - 234 g; females: 200 - 212 g
- Fasting period before study: feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum
- Housing: granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week. During the 14-day observation period the animals were kept singly in MAKROLON cages (type III).
- Diet: ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C +/- 3 °C (maximum range)
- Relative humidity: 55 % +/- 15 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: sesame oil
Details on dermal exposure:
TEST SITE
- Area of exposure: the hair on the site of application was clipped with hair clippers without causing injury approximately 24 hours before administration. The site was situated on the animal's back between the fore and hind extremities and had an area of at least 5 x 6 cm (approx. 1/10 of body surface). The test item was suspended in sesame oil to ensure good contact with the skin.
- Type of wrap if used: the test item suspension was applied to 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster on the application site.

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period no residual test item had to be removed.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the administration volume was 10 mL/kg bw.

VEHICLE
- Source: Henry Lamotte GmbH, 28197 Bremen, Germany
- Batch no.: 3753704

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days. During the follow-up period (two weeks), changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on mortality were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes, at the end of the experiments, all surviving animals were sacrificed, dissected and inspected macroscopically. No microscopic examination was performed as no gross pathological changes were recorded.
- Other examinations performed: The skin was observed for the development of erythema and oedema and was rated according to the Draize scale.
Statistics:
As no mortality did occur no LD50 could be calculated.

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.
Clinical signs:
A single dermal administration of 2000 mg SymWhite 377/kg b.w. to 5 male and 5 female rats did not reveal any clinical signs of toxicity.
Body weight:
The animals gained the expected weight throughout the whole study period.
Gross pathology:
No macroscopical changes were noted at necropsy.
Other findings:
No skin reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (male and female rats) > 2000 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic by the dermal route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic by the dermal route.

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