Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.5 kg
- Diet ad libitum
- Water ad libitum
- Acclimation period: 24 hours


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of each of the 3 rabbits
Amount / concentration applied:
undiluted
Amount applied: 100 /eyemg
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
up to 72 hours post exposure (reverible)
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after (see exposure time)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: over 72 hours
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 0.1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 0.2
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
see section "remarks on reslults including tables and figures"
Other effects:
no data

Any other information on results incl. tables

RS-Freetext:
AVERAGE SCORE
rabbit1/2/3, 1h-24 hrs-48 hrs-72 hrs - mean score:
-Cornea: 0/0/0-0/0/0-0/0/0-0/0/0 - 0 (max. possible: 4)
-Iris: 1/1/1-0/1/0-0/0/0-0/0/0 - 0.1 (max possible: 2)
-Conjunctivae (Redness): 2/2/3-2/3/2-1/2/2-0/0/0 - 1.3 (max. possible: 3)
-Conjunctivae (Chemosis): 2/2/2-0/1/1-0/0/0-0/0/0 - 0.2 (max. possible: 4)
discharge: all rabbits at 1 hour, rabbit 2 and 3 up to 24 hours post reading
REVERSIBILITY: within 72 hrs p.a.

Applicant's summary and conclusion

Executive summary:

1,2 -dichloro-4 -nitrobenzene applied into the conjunctival sac of the eye of rabbits caused slightly irritating effects which were reversible within 72 hours post application (Hoechst AG 1988)