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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
Study period:
11.3.80 - 14.3.80
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. No analytical purity of the test substance was given. The animals were treated on intact and abraded skin for 24 h under occlusive conditions, and no reading was performed after 48 h.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 2002)
Deviations:
yes
Remarks:
Six animals were used (intact and abraded skin); 24 h treatment under occlusive conditions; No reading after 48 hours
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
EC Number:
279-505-5
EC Name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
Cas Number:
80584-91-4
Molecular formula:
C21H36N6O6
IUPAC Name:
6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
Details on test material:
- Physical state: White powder

Test animals

Species:
rabbit
Strain:
Californian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12-16 weeks
- Average weight at study initiation: 2.41 kg (males), 2.21 kg (females)
- Housing: single housing
- Diet: commercial diet (Labsure, Christopher Hill Group), ad libitum
- Water: sterile filtered water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 ± 1
- Humidity (%): 50-70
- Photoperiod: artificial light from 08.00-18.00 hours.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, intact and abraded skin
Vehicle:
other: Polyethylene glycol (50% aqueous solution)
Controls:
not specified
Amount / concentration applied:
1 mL (corresponding to 500 mg test substance)
Duration of treatment / exposure:
24 hours
Observation period:
14 days intended, however study was terminated after 72 h because of negative results
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back, 2.5 cm x 2.5 cm
- % coverage: 10%
- Type of wrap if used: gauze pad covered with aluminum foil (covered by "COBAN" self adhesive bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 h

SCORING SYSTEM:
Draize scheme

SCORING TIME POINTS:
24 h: directly after patch removal
72 h: 48 h after patch removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
abraded skin
Time point:
24 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
abraded skin
Time point:
72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
abraded skin
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
abraded skin
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal reactions were recorded when tested on intact skin, all scores for erythema and edema were zero in all six animals. One animal showed minimal redness after 24 hours (score = 1) when treated on abraded skin, reversible within 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test article did not cause any signs of irritation when applied occlusively for 4 hours to the intact rabbit skin.
Executive summary:

The test article's potential to cause dermal irritation was assessed with an in vivo irritation study performed with six Californian rabbits. All animals were treated occlusively with 500 mg test material for 24 hours on either intact or abraded skin. The dermal reactions were recorded after 24 and 72 hours. All scores for erythema and edema were zero in all animals at all time points when treated on intact skin. Similar results were observed on abraded skin, only one animal showed minimal erythema formation at the 24 hour time point reversible within 72 hours. Therefore, based on the result of this study, the test article is not considered to be a skin irritant.

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