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EC number: 266-369-7 | CAS number: 66469-15-6
Eye irritation
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.
- 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.
The irritative phenomena were minor and not any lesion was seen after 48 hours.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- 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
Constituent 1
- 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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