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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-MAR-24 through 1992-May-01
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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
dilute test substance was also tested
GLP compliance:
yes (incl. QA statement)

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 92/600 154
- Physical state: viscous liquid
- Analytical purity: 98.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae, Biberach, Germany
- Weight at study initiation: 2.0 to 2.5 kg
- Housing: singly
- Diet: feed pellets ad libitum
- Water: free access to drinking water, acidified with hydrochloric acid to pH 2.5
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 55 +/-15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: ethanol (96%) and diethylphathalate; ratio 1:1 (w/w)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: 1, 10, 25, 50, 100% (w/w)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0 to 0.5 mL
- Concentration: 0 to 99%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: gauze patches were secured with adhesive tape and loosely fixed with Scanpor tape


REMOVAL OF TEST SUBSTANCE
- Washing: with soap and lukewarm water at the end of the 4-hour exposure period
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to the table contained in OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritant / corrosive response data:
No erythema or edema was noted during the study period in any animal with the unchanged or diluted test material.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU