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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 January 2001 - 21 January 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study and according to GLP.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
included in study report

Test material

Constituent 1
Reference substance name:
Sodium dicyanamide
IUPAC Name:
Sodium dicyanamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Description: white solid powder
Batch number: 1003
Purity: 97.5%
Storage: RT in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
The upper and lower eyelids were held together for about one second immediately after treatment. An assessment of the initial pain reaction was made accordingly.
Observation period (in vivo):
1 hour, 24, 48 and 72 hours
Number of animals or in vitro replicates:
A single rabbit was used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour, 24 hours
Score:
15
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 hours
Score:
30
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72 hours
Score:
45
Reversibility:
not reversible
Remarks on result:
other: animal humanely killed immediately after observation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour, 24 hours, 48 hours, 72 hours
Score:
5
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: at 72 hours animal was humanely killed immediately after observation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
12
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 hours, 48 hours
Score:
14
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 72 hours
Score:
16
Reversibility:
not reversible
Remarks on result:
other: animal humanely killed immediately after observation
Other effects:
Areas of diffuse corneal opacity were noted in the treated eye one and 24 hours after treatment with areas of translucent corneal opacity at the 48-hour observation and areas of opalescent corneal opacity at the 72-hour observation. Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48 and 72-hour observation. Furthermore, the animal was showing signs of pain and discomfort.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum total score of 66 and therefore, will be classified as Eye Damage 1, H318 according to GHS/CLP classification criteria.
Executive summary:

The substance was tested in a eye irritation study according to OECD 405, and GLP in year 2001. A single application of the test item to the non-irrigated eye of one rabbit produced opalescent corneal opacity, iridial inflammation and severe conjunctival irritation. The test material produced a maximum total score of 66 and therefore, will be classified as Eye Damage 1, H318 according to GHS/CLP classification criteria.