Registration Dossier

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:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
(Z)-docos-13-enamide
EC Number:
204-009-2
EC Name:
(Z)-docos-13-enamide
Cas Number:
112-84-5
IUPAC Name:
docos-13-enamide
Test material form:
other: solid, not further specified
Details on test material:
- Name of test material (as cited in study report): Erucamide
- Substance type: Fatty acid amide
- Physical state: solid
- Analytical purity: approx. 99%
- Storage condition of test material: At ambient temperature in the dark

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. 10 weeks
- Weight at study initiation: 2.07 - 2.51 kg
- Housing: Individually in plastic cages with perforated floors.
- Diet: Standard laboratory animal diet (LK-01 and LK-04, diameter 4mm; Hope Farms, Woerden, The Netherlands), 100 g/d
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20
- Humidity (%): 50-65
- Air changes (per hr): air conditioned, not further specified
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contralateral eye served as control
Amount / concentration applied:
60 ± 2 mg (approx. equivalent to 0.1 mL)
Duration of treatment / exposure:
Once, not washed out
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: pocket flash-light, 2% fluorescein in (adjusted to pH 7.0; 24 hours after instillation)

Each portion of the dispensed amount of 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 right eye, remaining untreated, served as a control.

Immediately after instillation of the test substance, the animals were observed and abnormalities were recorded. In addition, the eyes were examined approximately 60 minutes, 24, 48 and 72 hours and 7 days after instillation of the test substance. The examinations were performed using a pocket flash-light. Observed local (or systemic) effects other than those covered by the scoring system, were also recorded.

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
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:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Approximately 60 minutes after exposure two animals showed diffuse conjunctival redness and slight chemosis; the other animal showed slight conjunctival redness and slight chemosis. The conjuctival redness had resolved in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Treatment of the eyes with fluorescein 24 hours after exposure revealed no epithelial damage in any of the animals.
Other effects:
No signs of systemic intoxication were observed in any of the rabbits.

Any other information on results incl. tables

According to the criteria of 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 Criteria used for interpretation of results: EU
Conclusions:
Based on the estimated Draize score of 6 (60 minutes) the test substance should be classified as mildly irritating according to the scheme of kay and Calandra. According to the EEC criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye irritant.
Executive summary:

Instillation of approximately 60 mg of the test substance in one of the eyes of each of three albino rabbits resulted in slight to diffuse redness of the conjuctivae and slight chemosis. The conjuctival redness had resolved in one animal by day 3 and in the other two animals between days 3 and 7. The chemosis resolved within 24, 48 or 72 hours for each rabbit separately. Based on the estimated Draize score of 6 (60 minutes) the test substance should be classified as mildly irritating according to the scheme of Kay and Calandra. According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EC (amended by Directive 83/467/EEC), the test substance need not be labelled as an eye irritant.