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EC number: 629-719-3 | CAS number: 1219010-04-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 3 december 1984 - 10 december 1984
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD Guidelines for Testing of Chemicals (1981) 404 but limited report and no data on the identity and purity of the test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- (Only quality assurance statement indicating that at or about the time of the study, "process-based" inspections were made by the Quality Assurance Unit of the critical procedures relevant to this study type.)
Test material
- Reference substance name:
- N-C16-18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diamine
- EC Number:
- 629-719-3
- Cas Number:
- 1219010-04-4
- Molecular formula:
- Unspecified molecule and hence no molecular formula
- IUPAC Name:
- N-C16-18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diamine
- Details on test material:
- - Name of test material (as cited in study report): ARMOGARD C724
- Physical state: brown liquid
- Analytical purity: not stated
- Impurities (identity and concentrations): not stated
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits,Petersfield, Hampshire, UK.
- Age at study initiation: nine to thirteen weeks old
- Weight at study initiation: 2.1 up to 2.8 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes but duration not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted
- Observation period (in vivo):
- The eyes were examined 1 hour and 1, 2, 3, 4 and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes are not rinsed
SCORING SYSTEM:
Ocular responses were evaluated according to the scheme devised by DRAIZE JH and all (1944) Methods for the study of irritation and toxicity of
substances applied topically to the skin and mucous membranes. J.Pharm.Exp.Ther., 82 p 377 (see below).
TOOL USED TO ASSESS SCORE:
Observation of the eyes was aided by the use of handheld torch.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean value of the 24,48 and 72-hour readings)
- Time point:
- other: 24,48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean value of the 24, 48 and 72-hour readings)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Irritant / corrosive response data:
- A corneal opacity developped in one animal out of three. No iridial inflammation was seen in any of the animals. A diffuse crimson red colouration of the conjunctivae was seen in one animal and was accompanied by considerable swelling with partial eversion of the eyelids. Mild conjunctival
reactions only were seen in one animal.
Any other information on results incl. tables
INDIVIDUAL OCULAR RESPONSES
OCULAR REACTIONS AFTER INSTILLATION OF 0.1 ML
Rabbit n° and sex |
Region of eye |
One hour |
Day after instillation |
||||
1 |
2 |
3 |
4 |
7 |
|||
1667 Male |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae Redness |
2 |
2 |
2 |
2 |
0 |
0 |
|
Conjunctivae Chemosis |
2 |
1 |
2 |
2 |
0 |
0 |
|
1668 Male |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae Redness |
1 |
1 |
1 |
1 |
0 |
0 |
|
Conjunctivae Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
|
1669 Male |
Cornea |
0 |
1 |
1 |
2 |
1 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae Redness |
1 |
1 |
1 |
1 |
1 |
0 |
|
Conjunctivae Chemosis |
1 |
1 |
1 |
1 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- No rabbits had a mean score value equal or higher than 2 for corneal opacity. No animals had a mean score value equal or higher than 1 for lesion of the iris. No mean score value for redness of the conjunctivae and chemosis were equal or higher than 2.5 and 2 respectively. According to the
criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative
provisions relating to classification, packaging and labelling of dangerous substances, the test material is not classified Irritant. - Executive summary:
Materials and methods
According to OECD 405 (1981), 3 rabbits were instillated in one eye with 0.1 ml of Amine, N-tallow alkyltrimethylenedi-, the other eye acted as a control. Prior to test substance instillation, the eyes of each animal where examined to ensure that there was no pre-existing corneal damage or conjunctival inflammation. Observation and scoring of the ocular reactions were made 1 hour and 1, 2, 3, 4 and 7 days after instillation. Observation was aided by the use of a handheld torch.
Results and discussion
A corneal opacity developped in one animal out of three. No iridial inflammation was seen in any of the animals. A diffuse crimson red colouration of the conjunctivae was seen in one animal and was accompanied by considerable swelling with partial eversion of the eyelids. Mild conjunctival reactions only were seen in one animal.
No rabbits had a mean score value equal or higher than 2 for corneal opacity. No animals had a mean score value equal or higher than 1 for lesion of the iris. No mean score value for redness of the conjunctivae and chemosis were equal or higher than 2.5 and 2 respectively.
Conclusion
Amine, N-tallow alkyltrimethylenedi- was slightly irritating when instillated into the rabbit eye. According to EU criteria, the test material does not require classification for ocular effects.
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