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EC number: 920-008-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Oct. 1, 1990 - Oct. 4, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Oct. 1, 1990 - Oct. 4, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritant / corrosive response data:
- All six of the unwashed animals showed redness (score of 1) at the 1 and 24 hr observations. The three females and one male also showed chemosis (score of 1) at the 1 hr observation. All symptoms were resolved at the 48 hr observation. All three washed animals showed redness (score of 1) at the 1 and 24 hr observation. These symptoms were also resolved by the 48 hr observation.
- Other effects:
- No other effects were observed in any animal at any observation.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
This data is being read across from the source study that tested C9-C14 aliphatic solvents (2-25% aromatics) based on analogue read across.
Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Individual Eye Irritation Scores - Washed
Animal |
1 hr |
24 hrs |
48 hrs |
72 hrs |
|
9960-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9962-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9964-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
Individual Eye Irritation Scores - Unwashed
Animal |
1 hr |
24 hrs |
48 hrs |
72 hrs |
|
9954-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9956-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9958-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9957-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9959-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9961-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- C9-C14 aliphatic solvents (2-25% aromatics)
- IUPAC Name:
- C9-C14 aliphatic solvents (2-25% aromatics)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week
IN-LIFE DATES: From: Oct. 1, 1990 To: Oct. 4, 1990
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the non-treated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water 30 seconds after start of exposure. The eyes of the remaining 6 animals were unwashed.
- Observation period (in vivo):
- 72 hrs at which time no animals showed signs of irritation.
- Number of animals or in vitro replicates:
- 9 animals total
3 males and 3 females were used in the unwashed eye experiment
3 males were used in the washed eye experiment - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water. The eyes of the remaining 6 animals were unwashed.
- Time after start of exposure: 30 seconds after start of exposure
SCORING SYSTEM: According to EPA guidelines 81-4
TOOL USED TO ASSESS SCORE: All animals were examined with 0.2% fluorescein sodium ophthalmic solution at the 24 hr observation . Since no fluorescein staining was seen in any animal, the examination was not repeated at later observations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unwashed eyes
- Irritant / corrosive response data:
- All six of the unwashed animals showed redness (score of 1) at the 1 and 24 hr observations. The three females and one male also showed chemosis (score of 1) at the 1 hr observation. All symptoms were resolved at the 48 hr observation. All three washed animals showed redness (score of 1) at the 1 and 24 hr observation. These symptoms were also resolved by the 48 hr observation.
- Other effects:
- No other effects were observed in any animal at any observation.
Any other information on results incl. tables
Individual Eye Irritation Scores - Washed
Animal |
1 hr |
24 hrs |
48 hrs |
72 hrs |
|
9960-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9962-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9964-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
Individual Eye Irritation Scores - Unwashed
Animal |
1 hr |
24 hrs |
48 hrs |
72 hrs |
|
9954-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9956-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9958-M |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
0 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9957-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9959-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
|
9961-F |
Cornea, opacity |
0 |
0 |
0 |
0 |
Cornea, area |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva, redness |
1 |
1 |
0 |
0 |
|
Conjunctiva, chemosis |
1 |
0 |
0 |
0 |
|
Conjunctiva, discharge |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
