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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid, not further specified
Details on test material:
- Name of test material (as cited in study report): Stearyl stearamide
- Substance type: N-alkyl fatty amide
- Physical state: solid
- Analytical purity: >95%
- Lot/batch No.: RCD/SO 103
- Impurities (identity and concentrations): Stearic acid and stearylamine forming a salt with one another (concentration <5%).
- Stability under test conditions: Stable, not further specified.
- Storage condition of test material: At ambient temperature in the dark.
- Other: Supplier: Akzo Chemie Nederland B.V., Deventer, The Netherlands; substance may be absorbed by plastic.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 2.45-2.56 kg
- Housing: Individually in metal cages with perforated floors.
- Diet: Standard laboratory animal diet (LK-01, pellet diameter 4 mm; 100 g per day), obtained from Hope Farms, Woerden.
- Water: Tap-water, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 60-80
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eyes served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 90±1 mg (equivalent to 0.1 mL)

Test substance preparation: Test substance was ground to a fine powder using a mortar and pestle. On the day of dose administration three portions of 90±1 mg of the powder were dispensed in glass containers with screw caps.

Test substance administration: On administration one of the portions of the test substance was instilled into the conjunctival sac of the left eye of each animal using a spatula. The lids were then held gently together for two seconds and released. The other eye remained untreated and served as control. Immediately after instillation the animals were observed and abnormalities were recorded.
Duration of treatment / exposure:
Not washed out
Observation period (in vivo):
100 minutes, 24, 48 and 72 hours, 4 and 7 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Solution of 2% fluorescein approximately 24 hours after instillation, immediately after scoring of corneal opacity and alterations of iris and conjunctivae. The procedure was repeated for one of the animals 3 days after dose administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 5% of corneal area affected on day 1, fully reversible by day 3
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
At the first observation time hyperaemia of blood vessels of the conjunctivae, affecting the eyelids and the scleral conjunctivae, was observed in all animals; the eyelids were also slightly to moderately swollen. Increased lacrimation was observed in 2/3 animals. The swelling disappeared in all animals within the next 24 to 48 hours, whereas slight redness persisted for 2 to 4 days. On day 7 the conjunctival effects had disappeared in all animals.

Treatment of the eyes with fluorescein 24 hours after instillation of the test substance revealed 5% corneal epithelial damage in 1/3 animals, but no damage in the other two animals; when this procedure was repeated for the concerned animal on day 3 no epithelial damage was observed. Apart from this effect no adverse effects on the cornea and the iris were observed in any of the rabbits during the entire observation period.
Other effects:
Signs of systemic intoxication were not observed.

Any other information on results incl. tables

Conclusion:

According to the criteria of EU Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information