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Toxicological information

Skin irritation / corrosion

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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: Guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 1,2-dichloro-4-nitrobenzene, purity > 99 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-3.3 kg
- Diet ad libitum
- Water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
Concentration: 500 mg
Duration of treatment / exposure:
4 hour(s)
Observation period:
up to 72 hours post expossure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 cm²
- Type of wrap if used: guze patch with plaster and fixed by a semiocclusive wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60', 24 h, 48 h, 72 h post exposure
Score:
ca. 0.2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60', 24 h, 48 h, 72 h post exposure
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
see section "remarks on results including tables and figures"
Other effects:
no data

Any other information on results incl. tables

RS-Freetext:
scoring for erythema (maximum value possible: 4) // edema (maximum value possible: 4)
intact: 30-60 min-24 hrs-48 hrs-72 hrs - sum
rabbit 1: 2-1-0-0 - 0.3 // 1-0-0-0 -0
rabbit 2: 1-1-0-0 - 0.3 // 0-0-0-0 - 0
rabbit 3: 1-0-0-0 - 0 // 0-0-0-0 - 0

overall:
mean scores for erythema/scabbing: 0.2
mean scores for edema: 0.0

Applicant's summary and conclusion

Executive summary:

Following dermal application to the shaved , intact skin of 3 rabbits for 4 hours 1,2 -dichloronitrobenzene was evaluated as non-irritant (Hoechst AG 1988).