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Diss Factsheets

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
Study period:
March 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

1
Reference substance name:
Reaction mass of Benzeneethanol, 2-chloro-.alpha.-(1-chlorocyclopropyl)-.alpha.-(chloromethyl)- and Oxirane, 2-(1-chlorcyclopropyl)-2-[(2-chlorphenyl)methyl]-
EC Number:
929-889-1
Cas Number:
not available
IUPAC Name:
Reaction mass of Benzeneethanol, 2-chloro-.alpha.-(1-chlorocyclopropyl)-.alpha.-(chloromethyl)- and Oxirane, 2-(1-chlorcyclopropyl)-2-[(2-chlorphenyl)methyl]-

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 6.5 months
- Weight at study initiation: 2.3 -2.7 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml neat test item
Duration of treatment / exposure:
Twenty-four (24) hours after administration, the eyes were treated additionally with fluorescein and examined.
Observation period (in vivo):
Until the changes observed have completely subsided, however not for more than 21 days after application. Animals that do not reveal any lesions anymore for 24 hours following the first 72 hours of observation are sacrificed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
There were no systemic intolerance reactions.
24 hrs fluorescein test: no pathological findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Under the present test conditions (OECD TG 405), a single application of 0.1 ml of the test item per animal into the conjunctival sac of the right eye of three rabbits did not cause any changes at the examination time points 60 minutes, 24, 48 and 72 hours. The cornea, iris and eonjunctivae were not affected by instillation of the test compound. There were no systemic intolerance reactions.