Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline conform study, air changes per hour and removal of the test substance not mentioned

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

EC Number:

410-560-1

EC Name:

Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

Cas Number:

153519-44-9

Molecular formula:

C28 H28 N3 O4 + C12 H25 / C13 H27 (represents two main components)

IUPAC Name:

Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxy phenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source/Breder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2390-2540 g
- Housing:
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES:
Start of experiment: January 15, 1991
End of experiment: January 22, 1991

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: patches were moistened before application with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution):

VEHICLE: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
patches were moistened before application with 0.5 % (w/v) carboxymethylcellulose
in 0.1 % (w/v) aqueous polysorbate 80

Duration of treatment / exposure:

4h

Observation period:

The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches

Number of animals:

3 female

Details on study design:

TEST SITE
- Area of exposure: flanks
- % coverage: 36 cm2
- Type of wrap if used: gauze patch, loosely covered with an aluminum foil (approx. 36 cm ) and held in place for 4 hours by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not mentioned
- Time after start of exposure: not mentioned

SCORING SYSTEM: OECD scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: all time points

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: all time points

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: all time points

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: all time points

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: all time points

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: all time points

Score:

0

Max. score:

4

Irritant / corrosive response data:

Because reactions were observed within 72 hours after removing the
bandages, the observation period was extended to 7 days to determine
the reversibility of the skin reactions.
Although the test article was sticking to the skin up to the reading
24 hours, the evaluation of the skin reaction was not impeded.
The skin reactions observed were reversible until the end of the
observation period on day 7.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions the test article induced erythema, and edema reactions when applied to the clipped albino rabbit skin. Because the mean values of the recordings 24 t o 72 hours after application are below the threshold of significance (2 score for erythema or edema) the test item is classified as non-irritant according to the Commission Directive 83/467/EEC.