Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific principles and is acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine

EC Number:

425-020-0

EC Name:

Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine

Cas Number:

191680-81-6

Molecular formula:

C50H77N11O2-C168H230N32O8

IUPAC Name:

N2-(2-{[4,6-bis({butyl[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]amino})-1,3,5-triazin-2-yl](3-{[4,6-bis({butyl[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]amino})-1,3,5-triazin-2-yl]amino}propyl)amino}ethyl)-N2-(3-{[4,6-bis({butyl[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]amino})-1,3,5-triazin-2-yl]amino}propyl)-N4,N6-dibutyl-N4,N6-bis[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]-1,3,5-triazine-2,4,6-triamine

Details on test material:

- Physical state: Off-white powder
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: 1/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: controlled
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g/rabbit

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 females

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm surgical gauze patch; the patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed from the test site by gentle washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: Erythema with max. score of 1 in two animals was noted at 60 min time point, reversible within 24 hours.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

In two animals, slight erythemas (score = 1) were noted 30 - 60 minutes after patch removal and cleared by 24 hours. Edema was absent at all observation intervals.

Other effects:

There were no abnormal systemic signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

The test article caused only minimal skin reactions in 2/6 animals and is therefore considered to be not irritating to the rabbit skin.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404, six female New Zealand White rabbits were dermally exposed to the test item for four hours in a semi-occlusive manner. 0.5 g of the test substance was placed on a clipped but intact area of the torso and held in place by a gauze patch moistened with distilled water. After 4 hours the wrappings were removed and residual test article was removed from the test site by gentle washing with distilled water. Dermal reactions were then scored according to the Draize scoring system at 30-60 min, 24, 48 and 72 hours after removal of the test substance. Only minimal erythema reactions were observed in two animals, reversible within 24 hours. All other scores for erythema and edema were zero. There were no abnormal systemic signs noted during the observation period. Therefore, based on this result, the test substance is considered to be not irritating to the rabbit skin.