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EC number: 207-312-8 | CAS number: 461-58-5
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 28 (119), 5582, 1963 (published by the FDA of the USA) and Draize and Kelley (Drug. Cosmet. Industr. 71 (1952) 36)
- Deviations:
- yes
- Remarks:
- : no reading after one hour
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyanoguanidine
- EC Number:
- 207-312-8
- EC Name:
- Cyanoguanidine
- Cas Number:
- 461-58-5
- Molecular formula:
- C2H4N4
- IUPAC Name:
- 1-cyanoguanidine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually
- Diet: they received no hay or other extraneous material that might enter the eyes
- The eyes of the animals were examined before testing and only those animals without observable eye defects are used
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- - Single treatment
- test substance was allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid were then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material
- the untreated eye served as control
- the eyes were not washed following instillation and the animlas were released immediately - Observation period (in vivo):
- 24, 48 72 hours and 7 days after instillation of the test material
- Number of animals or in vitro replicates:
- six animals
- Details on study design:
- SCORING SYSTEM (FDA scoring scale):
- an animal is considered as giving a positive reaction if there is, at any of the readings:
* discernable opacity of the cornea (other than slight dulling of the normal lustre), or
* ulceration of the cornea, or
* inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection), or if such substances produce
* obvious swelling in the conjunctivae (palpebral and bulbar, excluding the cornea and the iris) with partial eversion of the lids, or
* diffuse deep-crimson red with individual vessels not easily discernible
- the test is considered positive if four or more of the animals in the test group of six rabbits exhibit a positive reaction
- if one animal exhibits a positive reaction, the test is regarded as negative
- if two or three animals exhibit a positive reaction, the test is repeated, using a different group of six animals
- the second test is considered as positive if three or more of the animals exhibit a positive reaction
- if only one or two of the animals in the second test exhibit a positive reaction, the test is again repeated with a different group of six animals
- should a third test be needed, the substance will be regarded as an irritant if two or more animals exhibit a positive response
TOOL USED TO ASSESS SCORE:
- oculat reactions are read using a binocular magnifying glass
- the diagnosis of corneal damage is confirmed, if necessary, by staining the eyes of the animals with fuorescein-impreganted papers
- after flushing the excess fluorescein solution, the eyes are examined in a dark room under ultraviolet illumination
A substance which has elicited corneal and/or iris lesions which have not cleared by the seventh day reading, is considerd a severe eye irritant.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- < 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: only in animal #3 cornea score 1; all others were scored 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- < 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: only in animal #3 iris score 1; all others were scored 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 1 - < 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: after 7 days animals # 4 and 6 were still scored 1 (scores after 24 h: > 1 and 1, respectively); all other animals were scored 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 1 - < 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: exception: animal #4, chemosis was fully reversible within 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 7 d
- Score:
- < 1
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - The test material caused slight corneal damage, slight irititis and moderate redness and swelling of the conjunctivae in one rabbit and slight redness of the conjunctivae in the other five rabbits.
- During the seven-day observation period these eye lesions recovered incompletely so that at the seventh day reading slight redness of the conjunctivae was still observed in two out of six rabbits. - Other effects:
- No other effects observed.
Any other information on results incl. tables
Table 2: Individual scores awarded to the ocular lesions elicited by Dicyandiamid
Rabbit No |
cornea |
iris |
conjuntivae |
|
redness |
chemosis |
|||
After 24 hours |
||||
1 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
> 1 |
1 |
3 |
1 |
1 |
< 2 |
2 |
4 |
0 |
0 |
> 1 |
1 |
5 |
0 |
0 |
1 |
1 |
6 |
0 |
0 |
1 |
1 |
After 48 hours |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
3 |
0 |
0 |
1 |
1 |
4 |
0 |
0 |
1 |
1 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
>1 |
1 |
After 72 hours |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
3 |
0 |
0 |
1 |
0 |
4 |
0 |
0 |
1 |
1 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
>1 |
0 |
After 7 days |
||||
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
1 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this test and according to the FDA-standard the test material is not considered to be an eye irritant.
- Executive summary:
In an acute eye irritation study according to FDA-standards, 0.1 ml of Dicyandiamid was instilled into the eyes of six albino rabbits (New Zealand White strain). Eyes were not washed afterwards. Animals then were observed after 24, 48, 72 hours and 7 days. Irritation was scored by the method of US EPA 560/6-82-001.
Under the experimental conditions employed, Dicyandiamid produced slight corneal damage, slight irititis and moderate redness and swelling of the conjunctivae in one rabbit and slight redness of the conjunctivae in the other five rabbits. During the seven-day observation period these eye lesions recovered incompletely so that at the seventh day reading slight redness of the conjunctivae was still observed in two out of six rabbits.
According to the FDA-standard the test material is not considered to be an eye irritant.
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