Registration Dossier
Registration Dossier
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EC number: 943-011-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 03 Jun -10 Jun 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP-Guideline study, tested with the source substance Decanoic acid, mixed esters with octanoic acid and propylene glycol (CAS 68583-51-7). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decanoic acid, mixed diesters with octanoic acid and propylene glycol
- EC Number:
- 271-516-3
- EC Name:
- Decanoic acid, mixed diesters with octanoic acid and propylene glycol
- Cas Number:
- 68583-51-7
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult animals
- Weight at study initiation: mean 2457.5 g
- Housing: single holding in cage
- Diet: Altromin-Haltungsdiät 2023 (Altomin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Identification of animals: Ear tattoo and cage labelling
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without wasching
- Observation period (in vivo):
- 72 h
Reading time points: 1, 6, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- PRELIMINARY CONTROL:
The eyes of the animals were visually controlled and with fluorescein, 24 h prior to application.
MAIN STUDY:
A control of the treated eye with fluorescein was conducted, 24 h after application and after macroscopic control of the eye.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Cornea: no effects were observed during the study period in any animal.
Iris: no effects were observed during the study period in any animal.
Conjunctivae: after 1 h mild redness was observed in 2 of 4 animals. In one of theses animals the effect was fully reversible within 6 h after application. The second animal showed mild redness until 6 h after application being fully reversible after 24 h as well.
Chemosis: no effects were observed during the study period in any animal.
Exudation: no effects were observed during the study period in any animal. - Other effects:
- No further local or systemic effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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