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EC number: - | CAS number: -
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP compliant guideline study, fully adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP compliant guideline study, fully adequate for assessment.
- Justification for type of information:
- ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The structures of the target and source substances are identical and differ only with respect to the ratio of enantiomers where the target substance is a single pure L-isomer and the source substance is an equimolar mixture of L and D isomers.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance, L-Citronellyl nitrile, is a mono-constituent substance (EC No. 695-909-8, CAS no. 35931-93-2).
The source substance, DL-Citronellyl nitrile, is a mono-constituent substance (EC No. 257-288-8, CAS no. 51566-62-2).
The source and target substances are both of high purity with a low concentration of impurities.
3. ANALOGUE APPROACH JUSTIFICATION
The read across hypothesis is based on structural similarity where the only difference between target and source molecules is the enantiomeric ratio. In a non-chiral environment the target and source chemicals will have identical properties but in the chiral environment of living organisms the enantiomers may possess different carcinogenicity and teratogenicity (in a chiral environment, stereoisomers might experience selective absorption, protein binding, transport, enzyme interactions and metabolism, receptor interactions, and DNA binding). Therefore, as a precaution for the developmental toxicity endpoint it is suggested that the NOAEL 250 mg/kg bw/day for L-Citronellyl nitrile is used instead of 500 mg/kg bw/day, as it is not known which form is more potent in vivo. All other endpoints are considered to be acceptable for this substance assuming that 50% of the target compound is available in the test material.
4. DATA MATRIX
Please refer to the data matrix included in the read-across justification document attached in Section 13.2. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , limited observation time
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG.
- Weight at study initiation: males: 2.85 and 2.98 kg, female: 3.27 kg.
- Housing: Individually in stainless steel cages with wire mesh walk floor (floor area: 40 cm x 51 cm). No bedding in the cages; sawdust in the waste trays.
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, D-4000 Düsseldorf 1, FRG (about 130 g per animal daily).
- Water: About 250 mL tap water per animal daily.
- Acclimation period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24.
- Humidity (%): 30 - 70.
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00a.m. - 18.00p.m./18 p.m. - 8a.m.). - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: Untreated eye.
- Amount / concentration applied:
- Undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- 8 days
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application site: Conjunctival sac of the right eyelid.
No wash out of substance. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not classified for eye irritation.
Individual eye irritation scores:
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
|
|
Opacity |
Area |
|
Redness |
Swelling |
Discharge |
1 hours |
1 |
0 |
0 |
0 |
3 |
1 |
2 |
|
2 |
0 |
0 |
0 |
3 |
1 |
2 |
|
3 |
0 |
0 |
0 |
3 |
1 |
2 |
24 hours |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
48 hours |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
72 hours |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
8 days |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , limited observation time
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,7-dimethyloct-6-enenitrile
- EC Number:
- 257-288-8
- EC Name:
- 3,7-dimethyloct-6-enenitrile
- Cas Number:
- 51566-62-2
- Molecular formula:
- C10H17N
- IUPAC Name:
- 3,7-dimethyloct-6-enenitrile
- Details on test material:
- - Name of test material: Citronellylnitril
- Test substance No.: 82/88
- Stable until: March 1984
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG.
- Weight at study initiation: males: 2.85 and 2.98 kg, female: 3.27 kg.
- Housing: Individually in stainless steel cages with wire mesh walk floor (floor area: 40 cm x 51 cm). No bedding in the cages; sawdust in the waste trays.
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, D-4000 Düsseldorf 1, FRG (about 130 g per animal daily).
- Water: About 250 mL tap water per animal daily.
- Acclimation period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24.
- Humidity (%): 30 - 70.
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00a.m. - 18.00p.m./18 p.m. - 8a.m.).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: Untreated eye.
- Amount / concentration applied:
- Undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- 8 days
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application site: Conjunctival sac of the right eyelid.
No wash out of substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Individual eye irritation scores:
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
|
|
Opacity |
Area |
|
Redness |
Swelling |
Discharge |
1 hours |
1 |
0 |
0 |
0 |
3 |
1 |
2 |
|
2 |
0 |
0 |
0 |
3 |
1 |
2 |
|
3 |
0 |
0 |
0 |
3 |
1 |
2 |
24 hours |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
48 hours |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
72 hours |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
8 days |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
Applicant's summary and conclusion
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.
