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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:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The source study was conducted with isooctadecanoic acid. The read across source substance is considered a structural analogue taking into account the physico-chemical properties (surface active properties, logKow, water solubility) and the chemical structure of the test item (potassium soap of isooctadecanoic acid). Besides published data on eye irritation properties of long chain fatty acids and their salts are considered relevant for this read across approach. The results of the source substance are considered relevant for human health endpoints skin irritation, eye irritation and consecutive risk assessment of local effects. See read across document for further details.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The source study was conducted with isooctadecanoic acid. The read across source substance is considered a structural analogue taking into account the physico-chemical properties (surface active properties, logKow, water solubility) and the chemical structure of the test item (potassium soap of isooctadecanoic acid). Besides published data on eye irritation properties of long chain fatty acids and their salts are considered relevant for this read across approach. The results of the source substance are considered relevant for human health endpoints skin irritation, eye irritation and consecutive risk assessment of local effects. See read across document for further details.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
Physical state: liquid
Analytical purity: no data
Storage condition of test material: at room temperature
Other: light yellow
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test animals
Source: Elevage des Feuilletas
Weight at study initiation: 2 ± 0.2 kg
Housing: individually housed in stainless steel cages (61x46x34 cm) with a grid floor
Diet (ad libitum): UAR 112
Water (ad libitum): tap water
Acclimation period: 4 days

Environmental conditions
Temperature (°C): 22 ± 5
Humidity (%): 55 ± 25
Air changes (per hr): 14
Photoperiod (hrs dark / hrs light): 12 per day, in a complementary way with natural and artificial lighting
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
other: the untreated eye served as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 h. Reading time points: 1, 24, 48, 72 h
Details on study design:
Scoring system: Draize score
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h reading
Irritation parameter:
conjunctivae score
Basis:
animal: at 24 h reading
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h reading
Irritant / corrosive response data:
A slight enanthema together with slight chemosis was observed in all 3 animals at the 1 hour reading. Enanthema remained during 48 hours in one animal and only 24 hours in the other two. Not any lesion of iris or cornea was recorded.

The irritative phenomena were minor and not any lesion was seen after 48 hours.

Interpretation of results:
GHS criteria not met
Conclusions:
According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.
Executive summary:

Under the conditions of the present OECD 405 study, a single application of the test item to rabbits produced slight irritant effects, which were fully reversible within 72 hours in all animals. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

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
Chemical structure
Reference substance name:
Isooctadecanoic acid
EC Number:
250-178-0
EC Name:
Isooctadecanoic acid
Cas Number:
30399-84-9
Molecular formula:
C18H36O2
IUPAC Name:
16-methylheptadecanoic acid
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): Prisorine 3505
Physical state: liquid- Analytical purity: approx. 100 %
Storage condition of test material: at ambient temperature in the dark
Other: stable at storage conditions
Specific details on test material used for the study:
Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
Physical state: liquid
Analytical purity: no data
Storage condition of test material: at room temperature
Other: light yellow

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test animals
Source: Elevage des Feuilletas
Weight at study initiation: 2 ± 0.2 kg
Housing: individually housed in stainless steel cages (61x46x34 cm) with a grid floor
Diet (ad libitum): UAR 112
Water (ad libitum): tap water
Acclimation period: 4 days

Environmental conditions
Temperature (°C): 22 ± 5
Humidity (%): 55 ± 25
Air changes (per hr): 14
Photoperiod (hrs dark / hrs light): 12 per day, in a complementary way with natural and artificial lighting

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
other: the untreated eye served as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 h. Reading time points: 1, 24, 48, 72 h
Details on study design:
Scoring system: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h reading
Irritation parameter:
conjunctivae score
Basis:
animal: at 24 h reading
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h reading
Irritant / corrosive response data:
A slight enanthema together with slight chemosis was observed in all 3 animals at the 1 hour reading. Enanthema remained during 48 hours in one animal and only 24 hours in the other two. Not any lesion of iris or cornea was recorded.

Any other information on results incl. tables

The irritative phenomena were minor and not any lesion was seen after 48 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.
Executive summary:

Under the conditions of the present OECD 405 study, a single application of the test item to rabbits produced slight irritant effects, which were fully reversible within 72 hours in all animals. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.

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