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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Acceptable for assessment but without detailed documentation. Study report meets basic scient ific p rinciples. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
other: Department of Transportation (DOT) regulations
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
other: METHOD FOR PRIMARY IRRITATION DEPARTMENT OF TRANSPORTATION ACT
Deviations:
not specified
GLP compliance:
no
Remarks:
study performed prior to GLP implementation

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dicyanoamide
EC Number:
217-703-5
EC Name:
Sodium dicyanoamide
Cas Number:
1934-75-4
Molecular formula:
C2HN3.Na
IUPAC Name:
sodium dicyanamide
Test material form:
solid

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
albino rabbits

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent skin
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
4 (initial reading directly after patch removal), 24 and 48 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1.5 x 1.5 inch (3.8 x 3.8 cm)
- Type of wrap if used: clear plastic trunk bands

REMOVAL OF TEST SUBSTANCE
- Washing (if done): following initial reading
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 4, 24, 48 hours

SCORING SYSTEM:
- Method of calculation: The primary irritation index was calculated by adding the values for erythema or eschar formation, and edema at 4, 24 and 48 hours on intact and abraded skin (12 values) and dividing by six to obtain an individual score on each rabbit.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal: #1 - #6
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal: #1 - #6
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The initial scores directly following the 4 hours exposure were 0 in all animals (intact skin).

Judgment is based on erythema and edema calculated as mean scores for each animal following grading at 24 and 48 hours after removal of the test material, in consideration of reversibility.

The following mean scores were calculated: erythema 0/0/0 and edema 0/0/0.
Other effects:
not reported

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

direct following patch removal

0/0/0

 0/0/0

24 h

 0/0/0

 0/0/0

48 h

 0/0/0

 0/0/0

72 h

 -/-/-

 -/-/-

Average 24h, 48h,

 0/0/0

 0/0/0

Reversibility*)

Average time (unit) for reversion

 

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Judgment is based on erythema and edema calculated as mean scores for each animal following grading at 24 and 48 hours after removal of the test material, in consideration of reversibility.

The following mean scores were calculated: erythema 0/0/0 and edema 0/0/0.
Executive summary:

In a primary dermal irritation study according to Department of Transportation (DOT) regulations, 6 albino rabbits of unknown sex were dermally exposed to 0.5 g of sodium dicyanoamide (100% a.i) to approx. 8 cm² skin surface (intact skin). The animals were subsequently exposed for 4 hours. Following initial reading, the test sites were washed.

 

The means of the erythema and edema evaluations at 4 (initial reading), 24 and 48 hours for the six animals after a four-hour exposure were 0 (erythema) and 0 (edema).

 

In this study, sodium dicyanoamide is classified as not irritating to rabbit skin according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).