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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-03-02 to 1987-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD) according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyruvaldehyde
EC Number:
201-164-8
EC Name:
Pyruvaldehyde
Cas Number:
78-98-8
Molecular formula:
C3H4O2
IUPAC Name:
2-oxopropanal

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: not specified
- Weight at study initiation: 2.35 (mean of two males); 2.11 (one female)
- Housing: Stainless steel cage with wire mesh walk floor (floor area: 40 x 51 cm)
- Diet: about 130 g /animal / day
- Water: about 250 mL tap water / animal / day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 1987-03-10 to 1987-03-25 (males) or to 1987-03-23 (female)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: as is (approximately 30% solution in water)
Duration of treatment / exposure:
not applicable (substance was not washed out)
Observation period (in vivo):
maximum observation period: 3 to 15 days (one male died prematurely)
Animal 1 (female, 0685): 15 days
Animal 2 (male, 0665): 15 days
Animal 3 (male, 0663): 48 h
(readings at 1h, 24h, 48h, 72h, 8d and 15d after application, where possible)
Number of animals or in vitro replicates:
3 rabbits (2 males, one female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: eye not washed out

SCORING SYSTEM: Draize Score

TOOL USED TO ASSESS SCORE: not documented

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72h (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72h (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 and 48 (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 8 days (no iris score documented on day 15)
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24,48 and 72h
Score:
0
Max. score:
2
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 and 48h
Score:
0
Max. score:
2
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal # 1 and # 2
Time point:
other: 24, 48 and 72h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 15 days (both)
Remarks on result:
other: both same mean score, both euthanised on d15 due to strong eye irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 and 48h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48 and 72h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 and 48h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritant / corrosive response data:
Both surviving rabbits were euthanased on day 15 due to severe irritation at the cornea (Draize score cornea: 3 or 4) and the conjunctiva (redness score: both 2; chemosis score: both 1).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information