Sodium dicyanoamide

Endpoint summary

Description of key information

The skin irritation study was performed 1975, following the DOT (Transport Classification) Guidelines, before GLP- and OECD-testing guidelines were available and in force and amended in year 1991. The intact and abraded skin of 6 albino rabbits was employed for this study. The material to be tested (0.5 mg) was introduced beneath the patch. The irritation index is 0.0 and therefore, the test item will be not classified as skin irritant to the rabbit skin.
The substance was tested in an 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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975-08-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: DOT (Transport-Classification) Guideliens

Deviations:

not specified

Principles of method if other than guideline:

The study was performed before GLP- and OECD-testing guidelines were available and in force. The intact and abraded skin of 6 albino rabbits was employed for this study.

GLP compliance:

no

Remarks:

GLP-guidelines not yet in force at date of the study

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

4, 24 and 48 hours on intact and abraded skin

Number of animals:

6 albino rabbits were employed for this study.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4, 24 and 48 hour

Score:

0

Max. score:

0

Reversibility:

no data

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4, 24 and 48 hours

Score:

0

Max. score:

0

Reversibility:

no data

Other effects:

No data available.

Skin reaction	Reading (hours)	Individual scores – rabbit no. & sex
		1	2	3	4	5	6
Erytehma/Eschar	4 24* 48* 72	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
Total of *                                     0           0           0            0           0         0
Mean values of *                         0.0         0.0        0.0         0.0       0.0       0.0
Oedema	4 24* 48* 72	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
Total of *		0	0	0	0	0	0
Mean values of *		0.0	0.0	0.0	0.0	0.0	0.0

 

Overall mean of * for Erythema/Eschar: 0.0

Overall mean of * for Oedema:               0.0

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The irritation index is 0.0 and therefore, the test item will be not classified as skin irritant to the rabbit skin.

Executive summary:

The study was performed 1975, following the DOT (Transport Classification) Guidelines, before GLP- and OECD-testing guidelines were available and in force and amended in year 1991 (Addendum to Lonza Report No. 0155). A couple of substances were tested in one study. The intact and abraded skin of 6 albino rabbits was employed for this study. A series of 6 rabbits was used for testing each substance. The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape (occlusive application). The material to be tested (0.5 mg) was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands.

The irritation index is 0.0 and therefore, the test item will be not classified as skin irritant to the rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

Reason / purpose for cross-reference:

reference to same study

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

Species:

rabbit

Strain:

New Zealand White

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
OECD Guideline study and according to GLP.

Justification for selection of eye irritation endpoint:
OECD Guideline study and according to GLP.

Effects on eye irritation: corrosive

Justification for classification or non-classification

The irritation index is 0.0 and therefore, the test item will be not classified as skin irritant to the rabbit skin. 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.