SDBR

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

424-970-3

EC Name:

-

Cas Number:

166255-23-8

Molecular formula:

C16-H14-O3.C6-H16-O3-Si

IUPAC Name:

Triethoxysilylpropyl Dibenzoyl Resorcinol

Test material form:

solid

Details on test material:

Appearance: light yellow solid

Specific details on test material used for the study:

Density: 1.08 kg/L
Storage conditions: at ambient room temperature

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:(WI) WU BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 194-206g (males), 143-175g (females)
- Fasting period before study: No
- Housing: During exposure period animals were housed individually.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

maize oil

Details on dermal exposure:

After the exposure period materials and residues were removed as much as possible. The animals were observed for mortality for 14 days.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were dosed at 5 mL/kg bw of a 400 mg/mL suspension of the test item.
Body weights were recorded at the start of the study, and on days 3, 7 and 14.
Clinical signs were observed at least once daily (including 1 hour and within 4 hours after dosing), skin effects were evaluated using the Draize system on day 1 after test item removal and on days 3, 7 and 14 of the study.
Gross necropsy was done at sacrifice (carbon dioxide).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs were observed after treatment of 5 males and 5 females with the 2000 mg/kg bw dose level.

Gross pathology:

Macroscopic examination of the animals at the end of the observation period did not reveal treatment-related gross changes.

Other findings:

Skin effects observed consisted of very slight erythema and very slight oedema in all treated rats on day 1 of the study. In addition, the 5 females showed very slight scaliness on day 3 of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an acute dermal toxicity study in male and female rats, the LD50 was found to exceed 2000 mg/kg bw.