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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:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 February 2001 - 18 March 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 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes (incl. QA statement)
Remarks:
included in the study report
Type of study:
guinea pig maximisation test

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Main study:
Intradermal Induction: 5% w/w in distilled water
Topical Induction: 25% w/w in distilled water
Topical Challenge: 25% and 10% w/w in distilled water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Main study:
Intradermal Induction: 5% w/w in distilled water
Topical Induction: 25% w/w in distilled water
Topical Challenge: 25% and 10% w/w in distilled water
No. of animals per dose:
Selection of concentration for main study (sighting test):
---------------------------------------------------
Selection for conc. for Intradermal Induction:
Four animals using concentrations of 1%, 5%, 10% and 25% w/w in distilled water

Selection of Concentration for Topical Induction:
Two animals, treated with four preparation of the test material, 10%, 25%, 50% and 75% in distilled water.
Selection of Concentration for Topical Challenge:
Two animals, treated with four preparation of the test material, 5%, 10%, 25% and 50% in distilled water.
Main Study:
-----------
A group of fifteen guinea pigs were used (ten test and five control).

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Positive responses (discrete or patchy to moderate and confluent erythema) were noted
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Positive responses (discrete or patchy to moderate and confluent erythema) were noted.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
discrete or patchy to moderate and confluent erythema was noted
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy to moderate and confluent erythema was noted.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Positive responses (discrete or patchy to moderate and confluent erythema) were noted
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Positive responses (discrete or patchy to moderate and confluent erythema) were noted.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
discrete or patchy to moderate and confluent erythema was noted
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy to moderate and confluent erythema was noted.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
2
Total no. in group:
5
Clinical observations:
Transient challenge reactions (discrete or patchy erythema) were noted
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 5.0. Clinical observations: Transient challenge reactions (discrete or patchy erythema) were noted.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were noted.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were noted..

Any other information on results incl. tables

Discrete or patchy to moderate and confluent erythema was noted at the intradermal induction sites of test group animals. No skin reactions were noted at the intradermal induction sites of control group animals. Discrete or patchy erythema was noted at the topical induction sites of all control group animals at the 1 -hour observation. No skin reaction were noted at the topical induction sites of control group animals at the 24 -hour observation. Bleeding from the intradermal injection sites was noted in all test group animals and four control group animals at the 1 -hour observation.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a 90% (9/10) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin under the conditions of the test. The test material produced a sensitisation rate of more than 30% and therefore, will be classified as skin sens. 1, H317 according to GHS/CLP
classification criteria.
Executive summary:

The substance was tested in a skin sensitisation study in the Guinea Pig (Magnusson and Kligman Maximisation Method) according to OECD 406, and GLP in year 2001. The test material produced a 90% (9/10) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin under the conditions of the test. The test material produced a sensitisation rate of more than 30% and therefore, will be classified as skin sens. 1, H317 according to GHS/CLP classification criteria.