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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-08-17 to 1999-08-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
January 1997
Deviations:
no
GLP compliance:
yes

Test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg, Germany
- Weight at study initiation: 2.3 - 2.4 kg
- Diet: rabbit diet "Altromin 2123" (supplier: Altromin, D-32791 Lage, Lippe, Germany), ad libitum.
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature:20 °C ± 3°C
- Humidity:55 % ± 15 %
- Air changes: 10 times/hour
- Photoperiod: cycle of 12 hours light and 12 hours darkness. Light was on from 06 to 18 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Only the left eye was treated. The right eye remained untreated and served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL of test item
Duration of treatment / exposure:
0.1 mL ofthe test article was placed in the left eye ofthe rabbits by gently pulling the lower Iid away from the eyeball to form a cup into which the test article was dropped. The Iids were then gently heldtagether for 1 second.
Observation period (in vivo):
The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. The eyes were also examined 48 and 72 hours after the treatment.
Number of animals or in vitro replicates:
three females
Details on study design:
The day before testing both eyes of the animals were examined with a hand held inspection lamp fitted with white and UV -light and magnifying glass with 2 x magnification to ensure there were no defects or irritation. The examination was performed before and after instillation of Fluorescein.
After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 mL 0.9 % sodium chloride solution the eyes were examined again using UV -light to detect possible corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 0, 24,48,72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean value
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean value
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean value
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean value
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean value
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean value
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 0, 24, 48, 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: mean value
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 0, 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: mean value
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 0, 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: mean value
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean value
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean value
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 0, 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: mean value
Irritant / corrosive response data:
After 72 hours all animals were free of any signs of eye irritation.

Any other information on results incl. tables

After 24 hours animal no. 1 and no. 2 showed some conjunctival vessels definitely injected. Some conjunctival vessels definitely injected and some swelling above normal was observed in animal no. 3. After 48 hours animal no. 1 showed some conjunctival vessels definitely injected. Animal no. 2 and no. 3 did not show any signs of eye irritation. After 72 hours all animals were free of any signs of eye irritation. Under the experimental conditions described the test item caused no evidence of skin irritation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU