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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation, other
Remarks:
In Vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, available as unpublished report, performed in a reliable laboratory (BASF), signed by key scientists, no GLP certificate, but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C5, ethylene-manuf.-by-product, hydrogenated
EC Number:
295-765-2
EC Name:
Hydrocarbons, C5, ethylene-manuf.-by-product, hydrogenated
Cas Number:
92128-68-2
IUPAC Name:
Hydrocarbons, C5, ethylene-manuf.-by-product, hydrogenated
Constituent 2
Reference substance name:
C5 produkt
IUPAC Name:
C5 produkt
Details on test material:
- C5 produkt
- no data (reported as available in the raw data)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Savo med Versuchsteirzuchten, GMBH, FRG
- Age at study initiation: no data
- Weight at study initiation: mean: 3.18 kg
- Housing: In stainless steel wire mesh cages
- Diet: Kliba 341 (approximately 130 g per animal per day)
- Water: approximately 250 mL per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes: Fully air conditioned
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: Dosed: 11 December 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the eyes were not washed

SCORING SYSTEM:
- According to the 83/467/EEC criteria of July 29th 1983
- Eyes examined at 1, 24, 48 and 72 hours after application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The overall mean score for conjunctival redness was 0.3, and for chemosis was 0.2. All eyes were normal 72 hours following instillation of the test substance.
Executive summary:

C5 Produkt (CAS 92128 -68 -2) was non irritating to the rabbit eye and does not warrant classification under DPD or GHS/CLP.