Sodium dimethyldithiocarbamate

Endpoint summary

Description of key information

SDDC is not irritating to skin or eyes.
skin irritation (OECD 404): not irritating
eye irritation (OECD 405): not irritating

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:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Individual bodyweights were not reported.

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2000-3500 g

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water
- Time after start of exposure: 4 h


SCORING SYSTEM:
According to Draize scoring system.
Erythema 0-4:
0: No erythema, 1: very slight erythema (barely perceptible), 2: well-defined erythema, 3 moderate to severe erythema, 4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema 0-4:
0: No oedema, 1: very slight oedema (barely perceptible), 2: well-defined oedema (edges of area well-defined by definite raising), 3: moderate to severe oedema (raised approximately 1mm), 4: severe oedema (raised more than 1 mm extending beyond the area of exposure)

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Observation time	Rabbit number and sex
	#29 male		#31 male		#45 male
	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
1 h	2	2	2	3	2	3
24 h	2	1	2	2	2	1
48 h	1	0	1	1	1	0
72 h	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	1.00	0.33	1.00	1.00	1.00	0.33
Reversibility	Yes	Yes	Yes	Yes	Yes	Yes

Interpretation of results:

not irritating

Remarks:

Migrated information

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:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Individual bodyweights were not reported.

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2000-3500 g

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

substance was not removed

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Cornea
Degree of Opacity 0 – 4 (0 = no finding, 1 = slight, disperse, diffuse opacity, 2 = extensive, diffuse opacity, iris blurred, 3 = mother-of-pearl-like opacity, iris and pupil hardly recognisable, 4 = complete opacity, ulceration)
Iris 0 – 2 (0 = no finding, 1 = swelling, reddening, positive light reaction, 2 = severe reddening and swelling, no light reaction)
Conjunctivae
Redness 0 – 3 (0 = blood vessels normal, 1 = vessels abnormally filled, 2 = diffuse reddening, 3 = diffuse deep reddening)
Chemosis 0 – 4 (0 = no swelling, 1 = slight swelling, 2 =severe swelling, lids everted, 3 = lids cover one half of eye, 4 = lids cover more than half eye, necroses and ulcers on the conjunctivas)


TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

	Cornea	Iris	Conjunctiva
			Redness	Chemosis
Score (average of animals investigated)	0 to 4	0 to 2	0 to 3	0 to 4
1 h	0.00	0.00	2.00	1.67
24 h	0.00	0.00	2.00	0.67
48 h	0.00	0.00	1.33	0.33
72 h	0.00	0.00	0.33	0.33
Average 24 h, 48 h, 72 h	0.00	0.00	1.22	0.44
Reversibility*	-	-	c	c
Average time for reversion	-	-	7 d	7 d
*             c :           completely reversible                 n c :        not completely reversible                 n :           not reversible

Interpretation of results:

not irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SDDC was tested on the skin and in the eye of rabbits. Only mild irritation was observed in both tests.

Justification for selection of skin irritation / corrosion endpoint:
The reliable GLP compliant OECD Guideline study was chosen.

Justification for selection of eye irritation endpoint:
The reliable GLP compliant OECD Guideline study was chosen.

Justification for classification or non-classification

SDDC was tested on the skin and in the eye of rabbits. Mild irritation was observed in both tests but the criteria of DSD or CLP for a respective classification are not fulfilled.