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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 June - 22 June 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC, see below).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
480-420-2
EC Name:
-
Cas Number:
144702-27-2
Molecular formula:
C33 H29 N5
IUPAC Name:
4'-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}-[1,1'-biphenyl]-2-carbonitrile
Test material form:
other: powder
Details on test material:
- Name of test material (as cited in study report): BIBR 277 Nitril
- Physical state: white to slight yellowish powder
- Analytical purity: 95.8%
- Lot/batch No.: HE818 Nitril

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology, Löhndorf, Germany
- Age at study initiation: 6.5 months
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: individually in 600mm x 425mm x 380 mm cages.
- Diet (e.g. ad libitum): ssniff (R) K-H V2333 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): each 12 hrs light/dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg test substance per animal
Duration of treatment / exposure:
4 hours
Observation period:
50 minutes, 24, 48 and 72 hours after treatment
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm², dorsal area of the trunk of the animals.
- Type of wrap if used: gauze patch, non-irritating tape

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EC directive 67/548/EEC BIBR 277 Nitril is classified as non-irritating.