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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-04-08 through 1992-04-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octocrilene
EC Number:
228-250-8
EC Name:
Octocrilene
Cas Number:
6197-30-4
Molecular formula:
C24H27NO2
IUPAC Name:
2-ethylhexyl 2-cyano-3,3-diphenylacrylate
Details on test material:
- Name of test material (as cited in study report): HR 92/600154
- Analytical purity: 98.5%
- Impurities (identity and concentrations):
- Physical state: viscous liquid
- Lot/batch No.: 2010002
- Stability under test conditions: yes
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd., Manston, Kent, U.K.
- Age at study initiation: 10 to 14 weeks
- Weight at study initiation: males 213-235 g; females 202-222 g
- Fasting period before study: not required
- Housing: singly until day 1 post treatment, in groups of 5 thereafter
- Diet: ad libitum (Rat and Mouse Expanded Diet No. 1)
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 52-60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5x4 cm
- % coverage: 10% of total body surface
- Type of wrap if used: surgical gauze, covered by a piece of self-adhesive bandage (HYPERTIE), secured with a piece of BLENDEM wrapped around each end


REMOVAL OF TEST SUBSTANCE
- Washing: with distilled water to remove excess test material
- Time after start of exposure: 24 hours after treatment


TEST MATERIAL
- Amount applied: 2000 mg/kg
- Constant volume or concentration used: yes

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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: observations at least once daily; weighing on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not needed

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity or skin irritation were noted during the study.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU