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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1'-ethane-1,2-diylbis(4-nitrobenzene)
EC Number:
212-001-5
Cas Number:
736-30-1
Molecular formula:
C14H12N2O4
IUPAC Name:
1,1'-ethane-1,2-diylbis(4-nitrobenzene)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.37 - 2.62 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K. ( ad libitum):
- Water: drinking water (ad libitum):
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 60 - 68
- Air changes (per hr): approximately 15
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: destilled water
Controls:
no
Amount / concentration applied:
0.5g of the test material, moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch secured with a strip of surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: with destilled water
- Time after start of exposure: 4 hous

SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 99, 161, 531 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time point
Irritation parameter:
edema score
Basis:
animal: # 99, 161, 531 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time point
Irritant / corrosive response data:
no signs of corrosion
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, DNBY, was found to be non-irritant to rabbit skin
Executive summary:

The substance was tested for skin irritation according to OECD guideline 404. 3 New Zealand White rabbits were exposed to 0.5 mg of the susbstance moistened with 0.5 ml of destilled water at the clipped intact skin. After removal of the semi-occlusive bandage no evidence of skin irritation was noted during the study period.