Registration Dossier
Registration Dossier
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EC number: 270-418-8 | CAS number: 68439-75-8 This substance is identified by SDA Substance Name: C12-C18 dialkyl methyl amine and SDA Reporting Number: 16-043-00.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1988-03-15 to 1988-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- There is no information of Amines, di-C12-18-alkylmethyl (CAS No.: 68439-75-8; EC No.: 270-418-8) itself but there is information available for Amines, di-C16-18-alkylmethyl (CAS No.: 1227096-04-9; EC No.: 627-132-7) which is structurally similar to Amines, di-C12-18-alkylmethyl.
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)
- Version / remarks:
- Reliability scoring based on 1987 guideline for test n°405
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC Number:
- 627-132-7
- Cas Number:
- 1227096-04-9
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- Test material form:
- liquid
- Details on test material:
- - Chemical name: N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC number: 627-132-7
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Konventionelle zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-2.9 kg
- Diet and water : ad libitum (diet: Altromin 2123)
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70
- Photoperiod : 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- - Amount applied :0.1 ml
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 1, 24 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : no
SCORING SYSTEM: according to guideline OECD 405
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: All individual scores were 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Individual mean scores for each animal: 0.7; 1.0 and 0.3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 72 hours
- Remarks on result:
- other: Individual mean scores for each animal: 0.3; 0.7 and 0.0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: All individual scores were 0
- Irritant / corrosive response data:
- At the 24-hour reading, slight (grade 1) and moderate (grade 2) rednesses of the conjunctivae were observed in 1 and 2 rabbits respectively. A slight chemosis (grade 1) was present in 2 out of 3 rabbits. The redness of the conjunctivae and the chemosis (grade 1) were still present at the 48-hour reading in 1 animal but the recovery was complete at the 72-hour reading time.
No lesions of cornea or iris were reported. (See Table 1 for complete raw data)
Any other information on results incl. tables
Individual scores for eye irritation:
| Time after application | 1 hr | 24 hrs | 48 hrs | 72 hrs | |||||||||
| Rabbit | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
| Scores | Chemosis | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Conjunctivae | 3 | 1 | 2 | 2 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Cornea opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean scores calculated for each animal over 24, 48 and 72 hours were (0.3) (0.7) and (0) for chemosis, (0.7) (1) and (0.3) for redness of the conjunctivae, (0) (0) and (0) for iris lesions and (0) (0) and (0) for corneal opacity.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
- Conclusions:
- Under these experimental conditions, the tested substance Genamin SH 301 is not classified according to CLP (Reg. n° 1272/2008/EC) and directive 67/548/EEC.
- Executive summary:
The potential of Genamin SH 301 to induce eye irritation was assessed in 3 rabbits according to the OECD guideline 405 and in compliance with the principles of Good Laboratory Practice regulations.
A single dose of 0.1ml of the test item was instilled into one eye, the other eye was not treated and served as control. The eyes were not rinsed after administration of the test item.
Ocular reactions were observed 1, 24, 48 and 72 hours. The values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were noted for each animal.Mean scores calculated over 24, 48 and 72 hours for the 3 animals were 0.3 for chemosis, 0.7 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 72 hours.
Under these experimental conditions, Genamin SH 301 was considered non- irritant when administered by ocular route to rabbits.
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