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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

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

Test material

Constituent 1
Reference substance name:
1-Octadecanol, phosphate, potassium salt
EC Number:
273-489-3
EC Name:
1-Octadecanol, phosphate, potassium salt
Cas Number:
68987-29-1
Test material form:
solid - liquid: suspension
Specific details on test material used for the study:
Silastol H 200
40 % suspension

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
- Weight at study initiation: 2.9 - 3.1 kg
- Housing: individually in PPO cages with perforated floor.
- Diet (e.g. ad libitum): Altromin 2123 from Altromin, D-32791 Lage, Lippe, ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 ml of the undiluted test article
Duration of treatment / exposure:
no washing
Observation period (in vivo):
7 days
Details on study design:
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 as well as 7 days after the treatment.

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
according to OECD guideline 405
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 as well as 7 days after the treatment.


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Fluorescein after 24 hours, UV-light was used to detect possible corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 2,3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 2,3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Very well-defined signs of irritation were observed on the treated eyes.
All effects were fully reversible within 7 days.
Individual data are presented in the table below.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Classification is based on individual mean scores of 24, 48 and 72 hour scorings, considering reversibility.
Executive summary:

In a primary eye irritation study according to OECD guideline 405, 0.1 mL of 1-Octadecanol, phosphate, potassium salt was instilled into the conjunctival sac of 3 adult New Zealand white rabbits. Animals then were observed for 7 days. Irritation was scored according to OECD guideline 405. Very well-defined signs of irritation were observed on the treated eyes of all animals including effects on cornea, iris and conjunctivae. All effects were fully reversible within 7 days.

Mean grades of ocular reactions at 24, 48 and 72 h after instillation were evaluated for classification purpose. Based on mean conjunctivae scores of 2.67/ 2/ 2, classification in category 2 is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).