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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:
1992-11-09 to 1992-12-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1987-02-24
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octanoic acid, zinc salt, basic
EC Number:
291-793-4
EC Name:
Octanoic acid, zinc salt, basic
Cas Number:
90480-58-3
Molecular formula:
(C8H15O2) 2Zn
IUPAC Name:
Octanoic acid, zinc salt, basic
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- Source: Thomae GmbH, D-Biberach
- Age at study initiation: approx. 10 and 22 month
- Weight at study initiation: approx. 2830 g
- Housing: individual accommodation
- identification of animal: ear tattoos and cage label
- Diet (ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, D-Soest; Charge: 770992/09)
- Water (ad libitum): tap water
- Acclimation period: 7/8 days

ENVIRONMENTAL CONDITIONS:
- Temperature: approx. 20 to 25 °C
- Relative humidity: approx. 45 to 70 %
- Air changes: at least 8 per hour
- Photoperiod (hrs dark / hrs light): artificial fluorescent light/ 12 hours dark







Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.1 mL of the undiluted test substance Stabiol VZN 1950 was placed in the conjunctival sac of the right eye. The left one remained untreated and served as the control.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours as well as 7, 14 and 21 days after exposure
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
According to the guidelines in a preliminary study one animal was treated because of the risk of severe eye injury.
Two additional experimental animals were treated in the same way.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were thoroughly rinsed with tepid tap water to complete the exposure.
- Time after start of exposure: 24 hours after instillation

SCORING SYSTEM: according to Draize scale

TOOL USED TO ASSESS SCORE:
Prior to the treatment, the eyes were examined by slit lamp microscope (Typ HSO-10; Fa. Carls Zeiss, Oberkochen) for their state of health and were judged to be healthy.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48,72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48,72 hours
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24,48,72 hours
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
Preliminary test: mild to strong erythema, weak to mild oedema and moderate to strong lacrimation were observed up to 72 hours after exposure. Weak corneal opacities were observed additionally up to 72 hours. All reactions disappeared completely within 14 to 72 hours. All reactions disappeared completely within 14 days.
Two further rabbits: the mild to strong erythema, mild to moderate oedema and mild to strong lacrimation at the other two experimental animals did not disappear within 72 hours. Weak to mild corneal opacities were observed additionally up to 72 hours. All reactions disappear completely within 22 days.

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritating to eyes)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material is irritating to the eyes. The effects are reversible. According to 67/548/EC and subsequent regulations, the substance is classified as an eye irritant. According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is classified as Category 2 (H319: Causes serious eye irritation).