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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, B.3. "Acute Toxicity-Dermal"
Version / remarks:
July 31, 1992
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol
Cas Number:
1248-66-4
Molecular formula:
C21H16N4O2
IUPAC Name:
2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf/Switzerland
- Age at study initiation: Males: 8 weeks. Females: 11 weeks.
- Housing: During acclimatization in groups of 5 per sex in Makrolon type-4 cages with standard
- Diet: ad libitum. Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 89/06)
- Water: ad libitum. Community tap water from Füllinsdorf

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod: automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- % coverage: 10% of the total body surface
-warap: elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water and dried with disposable paper towels;
- Time after start of exposure: 24h;

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 ml
-concentration: 0.25 g/ml
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 8 ml
- Concentration (if solution): 0.25 g/ml
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
OBSERVATION
Mortality/Viability: daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
Local signs: Once daily during days 2-15.

PATHOLOGY
Necropsies were performed. All animals were killed at the end of the observation period by Carbon dioxide asphyxiation.
Statistics:
No statistical analysis was used.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No death occured during the study.
Clinical signs:
other: All female animals and two male animals showed a slight erythema after removal of the dressing on day 2. The erythema persisted as slight until test day 4 to 6
Body weight:
other body weight observations
Remarks:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 (male and female rats) > 2000 mg/kg bw
Executive summary:

The acute dermal toxicity of the test item was evaluated in an experimental study according to the OECD Guideline 402 and Directive 92/69/EEC, B.3, "Acute Toxicity-Dermal", July 31, 1992.
Five male and five female HanRcc:WIST (SPF) rats were treated with test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.25g/mL and administered at a volume dosage of 8 mL/kg. The application period was 24 hours.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.


No death occurred during the study. All female animals and two male animals showed a slight erythema after removal of the dressing on test day 2. The erythema persisted as slight until test day 4 (two males and two females), 5 (one female) or 6 (two females). 


The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.


In conclusion, the LD50 after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg bw.