Registration Dossier
Registration Dossier
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EC number: 204-688-5 | CAS number: 124-19-6
Endpoint summary
Administrative data
Description of key information
The test substance was assessed for skin and eye irritation. There was potential for skin irritation, according to Regulation 67/548/EEC (DSD). There was no potential for eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-11-08 to 1988-11-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well docmented and acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive L251 of 1984-04-25
- Principles of method if other than guideline:
- 4 rabbits dermally exposed to 0.5 mL of test material semi-occlusively for 4 hrs, observed for 7 d
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Nonanal, CAS No. 124-19-6
- Substance type: Fragrance material
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: In the dark at approx. 4 °C - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gorseside Rabbits, Northchurch, Berkhamsted, Hertfordshire, United Kingdom
- Age at study initiation: 10-12 wks
- Weight at study initiation: approx. 2 kg
- Housing: Individually in grid-bottomed metal cages
- Diet: Commercial antibiotic-free pellet diet ad libitum
- Water: Mains water ad libitum
- Acclimation period: ≥ 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 17- 23 °C typically; dropped to 5 °C temporarily during acclimation due to heating failure
- Humidity: 37 % - 68 %
- Air changes (per hr): No data
- Photoperiod: 12 hrs dark / 12 hrs light) - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Volume applied: 0.5 mL - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 7 d (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs, 7 d)
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: Lint held in place with "Elastoplast" elastic adhesive bandage 10 cm wide
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool in warm water.
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Standard Draize - Irritation parameter:
- erythema score
- Basis:
- animal: 349
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritation parameter:
- edema score
- Basis:
- animal: 349
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 1.17
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal: 370
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritation parameter:
- edema score
- Basis:
- animal: 370
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 1.5
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal: 374
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritation parameter:
- edema score
- Basis:
- animal: 374
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 1
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal: 381
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 2.17
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritation parameter:
- edema score
- Basis:
- animal: 381
- Time point:
- other: Mean of 24, 48, 72 hrs
- Score:
- 2.17
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Irritant / corrosive response data:
- Marked desquamation at 7 d
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was assessed for skin irritation in rabbits following a 4 hour exposure period. The results indicate that the test material was irritating to skin as the mean erythema score was 2.0 in all 4 animals which was equal to the threshold value of 2.0 under Regulation 67/548/EEC (DSD).
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 November 1980 to 17 November 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C-193; SN 2188-3; Aldehyde C9 Nonylic
- Appearance: Colourless liquid
- Storage condition of test material: Room temperature (stored under nitrogen) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratory Animals, Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: 2.2 to 2.9 kg
- Housing: Animals were housed individually in suspended stainless steel cages
- Diet: Purine rabbit chow, available ad libitum
- Water: Automatic watering system (municipal water supply) available ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 20.5 °C; monitored twice daily
- Humidity: monitored daily
- Photoperiod: 12 hours light, 12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as the control.
- Amount / concentration applied:
- 0.1 mL of the test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to prevent loss of material.
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- Up to 7 days
- Number of animals or in vitro replicates:
- 9 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The treated and control eyes of 6 animals remained unwashed. Twenty seconds after the test substance was administered, both eyes of the remaining 3 animals were rinsed for one minute with lukewarm water.
OBSERVATIONS
-Viability checks were performed twice daily.
- Evaluations of eye irritation were performed approximately 24, 48 and 72 hours and 4 and 7 days after treatment. If there were no signs of irritation on Day 7, no additional observations were made.
- At each interval the treated and control eyes were examined and scored for ocular reactions. Unusual effects were also noted when present.
SCORING SYSTEM: Draize scale (see Appendix A in section "Attached background material")
TOOL USED TO ASSESS SCORE: Fluorescein dye - Irritation parameter:
- cornea opacity score
- Basis:
- animal: All animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: All scores were 0
- Irritation parameter:
- iris score
- Basis:
- animal: All animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: All scores were 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.33
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean score for redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1.67
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean score for redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean score for redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean score for redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean score for redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1.67
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean score for redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Mean score
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: Mean of 24, 48 and 72 h scores
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean score
- Irritant / corrosive response data:
- All nine rabbits exhibited positive scores for conjunctival redness and five animals with unwashed eyes showed positive scores for conjunctival chemosis. Conjunctival necrosis was observed in three animals with unwashed eyes. A positive score for iridial irritation was observed in one rabbit with washed eyes. All animals were free of signs of ocular irritation within seven days after administration of the test material.
The individual scores are given in Table 1.
The results from the animals whose eyes were washed have not been included as part of the classification assessment. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was assessed for eye irritation according to EPA OPP 81-4. The test material is not considered to be an eye irritant and is not classified according to Regulation No. 1272/2008.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Table 1: Individual ocular scores
- |
Time after administration |
|||||
24 hours |
48 hours |
72 hours |
4 days |
7 days |
||
Animal No. 6408F |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
2 |
0 |
1 |
0 |
|
Chemosis |
2 |
1 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
0 |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6409M |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
2 |
1 |
0 |
0 |
|
Chemosis |
2 |
1 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
N |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6410F |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
3 |
2 |
1 |
0 |
0 |
|
Chemosis |
2 |
1 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
0 |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6411M |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
2 |
2 |
0 |
0 |
|
Chemosis |
2 |
1 |
0 |
0 |
0 |
|
Discharge |
1 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
N |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6412F |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
0 |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6415M |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
2 |
1 |
0 |
0 |
|
Chemosis |
2 |
1 |
0 |
0 |
0 |
|
Discharge |
2 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
N |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6414Fb |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
0 |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6417Mb |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
0 |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
Animal No. 6418Fb |
Conjunctivae: |
- |
- |
- |
- |
- |
Redness |
2 |
1 |
1 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
Necrosis (N) |
0 |
0 |
0 |
0 |
0 |
|
Ulceration (U) |
0 |
0 |
0 |
0 |
0 |
|
Iris |
1 |
1 |
0 |
0 |
0 |
|
Cornea |
- |
- |
- |
- |
- |
|
Opacity |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
0F |
0F |
0 |
0 |
0 |
|
F: Observation confirmed with fluorescein
b: Both eyes were rinsed for one minute with lukewarm water 20 seconds after dosing
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The key study report indicated that the test material was irritating to skin as the mean erythema score was 2.0 in all 4 animals which was equal to the threshold value of 2.0 under Regulation 67/548/EEC. Within the framework of Regulation (EC) No. 1272/2008, which uses a threshold of 2.3 rather than 2.0, this result is negative.
Eye irritation
In the key study, the test substance was found not to be irritating to eyes.
Justification for selection of skin irritation / corrosion
endpoint:
Key study that meets generally accepted scientific standards, well
documented and acceptable for assessment.
Justification for selection of eye irritation endpoint:
Key study performed according to a guideline, with acceptable
restrictions.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
The test substance was assessed for skin and eye irritation. There was no potential for skin irritation within the framework of Regulation (EC) No. 1272/2008 (CLP), however in accordance with Regulation 67/548/EEC the test substance is classified as a skin irritant.
There was no potential for eye irritation.
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.
