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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:
July 27 - August 06, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to GLP.

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:
(1987)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C6-24 and C6-24-unsatd., distn. residues
EC Number:
310-079-6
EC Name:
Alcohols, C6-24 and C6-24-unsatd., distn. residues
Cas Number:
102242-48-8
Molecular formula:
Not available due to the complexity of the substance
IUPAC Name:
Alcohols, C6-24 and C6-24-unsatd. even numbered, distn. residues
Details on test material:
- Name of test material (as cited in study report): Pernil RU, Espum EGA 213
- Chemical designation: 18:1 fatty alkohol, unsaturated, distillation residue
- Physical state: brown liquid
- Analytical purity: 100%
- Lot/batch No.: Charge of laboratory, no batch number given
- Expiration date: December 31, 1995
- Stability: yes
- Storage: at room temperature

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, Biberach, Germany
- Age at study initiation: approx. 18 months
- Weight at study initiation: approx. 2.85 kg
- Housing: individually
- Diet: Ssniff rabbit diet K4 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 8 and 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes: 8/h
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h
- Other: music was offered during light hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
An amount of 0.1 mL of unchanged test material was applied into the conjunctival sac of the right eye of each test animal.

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Reading time points: 1, 24, 48, 72 h
Number of animals or in vitro replicates:
As recommended by the guideline, first one animal was treated, and depending on the severity of the results, two further animals were treated analogically one week later.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (tap water)
- Time after start of exposure: 24 h

SCORING SYSTEM
The assessment of the findings was based on the Draize Scoring System, as recommended by the current testing guideline (Draize JH, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity, 46-59, 1959).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2 and 3, respectively
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed corneal opacity
Irritation parameter:
iris score
Basis:
animal: 1, 2 and 3, respectively
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed effects in the iris
Irritation parameter:
conjunctivae score
Basis:
animal: 1 and 2, respectively
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: in 2/3 animals, no conjunctival redness was observed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: the third animal showed a transient redness of the conjunctiva graded 1 at reading time point 24 h only
Irritation parameter:
chemosis score
Basis:
animal: 1, 2 and 3, respectively
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed chemosis
Irritant / corrosive response data:
Following treatment, the first test animal displayed erythema grade 1 accompanied by discharge grade 2 at reading time point 1 h only. The second animal showed no eye reaction at all, whereas the third one had discharge grade 2 at reading time point 1 h, and conjunctival redness at 24 h.
Other effects:
In two cases, transient discharge grade 2 was noticed at reading time point 1 h only.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified