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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The exposure time was 24 hours (occlusive); observation at 24 and 72 hours after the start of application.
Qualifier:
according to guideline
Guideline:
other: US FHSA Federal regulation: 16 CFR 1500.41
Deviations:
no
GLP compliance:
no
Remarks:
study performed before implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
6-nonyl-1,3,5-triazine-2,4-diamine
EC Number:
227-645-2
EC Name:
6-nonyl-1,3,5-triazine-2,4-diamine
Cas Number:
5921-65-3
Molecular formula:
C12H23N5
IUPAC Name:
6-nonyl-1,3,5-triazine-2,4-diamine
Test material form:
solid: bulk

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped; intact and abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 (intact skin) + 6 (abraded skin)
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- Type of wrap if used: surgical patch fixed by adhesive tape and wrapped with an impervious material

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM:
- Draize (J. Pharmacol. 82 (1944) 377-390)
- CIVO-grading system (1973)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no irritant/corrosive effects in any animal with intact skin
One animal with abraded skin showed very slight erythema (grade 1) at the 24 hour time point. After 72 hours no skin reactions were observed in any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Caprinoguanamine was not irritating to skin. There were no skin effects observed in any animal with intact skin at 24 and 72 hours.
Executive summary:

In a primary dermal irritation study according to US FHSA Federal regulation: 16 CFR 1500.41 and similar to OECD Guideline 404, adopted 24 April 2002, 6 adult New Zealand white rabbits with intact skin were dermally exposed 24 hours to 0.5 g of Caprinoguanamine on 6.45 cm² skin surface. Animals were then observed for 72 hours. In addition, 6 rabbits with abraded skin were exposed under the same conditions.

Irritation was scored by the method of Draize (J. Pharmacol. 82 (1944) 377-390) and the CIVO-grading system (1973).

There were no skin effects observed in any animal with intact skin at 24 hours. One animal with abraded skin showed very slight erythema (grade 1) at the 24 hour time point. After 72 hours no skin reactions were observed in any of the rabbits. The result of the study is regarded as relevant and reliable although there are protocol deviations from the OECD 404 guideline (longer exposure time, shorter observation time).

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