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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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 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 guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
, compared to the recent version of OECD TG 404 (2002), testing was performed under occlusive conditions instead of semi-occlusive conditions.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
2-Hydroxy-4,6-diphenyl-l, 3,5-triazin
IUPAC Name:
2-Hydroxy-4,6-diphenyl-l, 3,5-triazin
Details on test material:
- Name of test material (as cited in study report): FAT 92376/A
- Physical state: solid, white crystals
- Analytical purity: 98%
- Lot/batch No.: 10.26
- Storage condition of test material: room temperature
- Other:
Test material received: 11 Feb 1993

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: New Zealand White (Chbb:NZW) rabbits from Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: no data
- Weight at study initiation: 2610 - 2770 g
- Housing: single housing in metal cages
- Diet (e.g. ad libitum): Standard rabbit pellet (Nafag No 814), Gossau, Switzerland
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- Photoperiod:12 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: The test material was moistened with the vehicle.
Duration of treatment / exposure:
4 h
Observation period:
72 h (observation period was shortened because of the lack of skin reactions 24, 48, and 72 after patch removal)
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze patch (12-16 cm2)
The patches were loosely covered with an aluminium foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

SCORING SYSTEM: Draize scheme

Observation of systemic symptoms and mortality: once daily
Evaluation of skin reactions: 1, 24, 48, and 72 hours after removing of gauze patches.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no findings
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no findings
Irritant / corrosive response data:
No findings were observed at the side of the test patches in any of the animals. After 1 h an erythema score of 1 was observed in 2/3 animals. These findings were fully reversible within 24 h. No scores higher than 0 for erythema and edema were observed in any animal at the time points 24, 48, and 72 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information