Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
p-Chlorobenzyl chloride, pure.
State of matter: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Rabbits, strain: New Zealand White
- Source: Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: 3 kg
- 2 males, 1 female

ENVIRONMENTAL CONDITIONS
- Diet: mümmel Z 222 (Hoeing Kraftfutterwerk Niedersachsen, Verden/Aller)
- Water: tap water (ad libitum)
- Temperature (°C): 19 - 21 °C
- Humidity: 40 - 50 %
- Photoperiod (hrs dark / hrs light): 12 / 12
- Housing: 1 animal per cage

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of test animal
Amount / concentration applied:
undiluted
Amount applied: 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Eyes were inspected for integrity before the testing.
The test substance was placed in the conjunctival sac of one eye of each animal.
The lids are then gently held together for about one second. The other eye, which remains untreated, serves as a control.
Eyes were rinsed with physiological saline 24 hours after instillation.
Eyes were examined 1, 24, 48, 72 and 168 hours after application.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
4
Max. score:
110
Remarks on result:
other: Classification: slightly irritating

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Due to the result p-Chlorobenzylchloride is not subject to specific labelling under current EU regulations.
Executive summary:

In an eye irritation study 0.1 g of undiluted p-chlorobenzyl chloride was instilled into the conjunctival sac of one eye of New Zealand White Rabbits (3 animals) for 24 hours. After 24 h eyes were rinsed with physiological saline.

The untreated eye served as control.

Animals were observed for 7 days.

Observation of the eyes occurred 1 h, 24 h, 48 h, 72 h and 7 days after application of the test substance.

Eye irritation was scored according to OECD GL 405.

The calculated overall irritation score is 4.

In this study, p-chlorobenzyl chloride exhibited a slight irritating potential.