N-alkylester N-aryl substituted aryl diazo aryl amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 to 19 Dec 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to OECD 402 and GLP guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Name: DYNS 2246

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species and strain: CRL:(WI)BR Wistar rats
Source: CHARLES RIVER (EUROPE) LABORATORIES INC. TOXI-COOP Ltd. 1103 Budapest, Cserkesz u. 90.
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Justification of strain: The Wistar rat as a rodent is one of the standard species of acute toxicity studies
Number of animals: 5 animals/sex
Sex: Male and female, female rats were nulliparous and non-pregnant.
Age of animals: Young adult rats (females: 8 weeks, males: 7 weeks)
Body weight range at dosing: Between 202 g and 262 g
Acclimatization time: 9 days
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding – Lignocel Hygienic Animal Bedding
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.1-24.6 °C
Relative humidity: 30-60 %
Ventilation: 8-12 air exchanges/hour.
Enrichment: Rodents are housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
Food: ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" ad libitum
Water: tap water ad libitum

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: 10 % area of the total body surface
- Type of wrap if used: semi occlusive plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water of body temperature
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

PRE-EXPERIMENTAL PERIOD
Animal receipt: Day [-8]
Veterinary control: Day [-8 to Day [-1]
Animal identification: Day [-1]

TREATMENT PERIOD
The day of treatment: Day 0
Body weight measurement: Day 0, 7, 14
Clinical observation: 1 and 5 hours after treatment, then daily for at least 14 days
Necropsy: Day 14

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: no clinical signs were observed

Gross pathology:

no test item related findings

Other findings:

OBSERVATION OF LOCAL DERMAL SIGNS: purple staining of the treated area was observed up to and including Day 8 in one animal and up to and including Day 7 in nine animals.

Any other information on results incl. tables

	Male	Female
Dose (mg/kg bw)	2000	2000
Number of animals treated:	5	5
Mortality:	0/5	0/5

No clinical signs were observed after treatment with the test item or during the 14‑day observation period.

After treatment with DYNS 2246, purple staining of the treated area was observed up to and including Day 8 in one animal and up to and including Day 7 in nine animals. This is related to the test item’s intended use as textile dye.

Body weight and body weight gains of DYNS 2246-treated animals did not show any test item related effect.

There was no evidence of DYNS 2246-related macroscopic findings at a dose level of 2000 mg/kg bw.

The following macroscopic signs were recorded:

• Dilatation of the pelvis in right kidney, diffuse dark red discoloration of the lung, pale areas on the lung

The macroscopic findings detailed above are common observations and were considered as agonal or incidental changes unrelated to treatment.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions described in this report, the acute dermal median lethal dose (LD50) of the test item DYNS 2246 was higher than 2000 mg/kg body weight in male and female CRL:(WI) BR rats.

Executive summary:

An acute dermal toxicity study was performed with test item DYNS 2246 in CRL:(WI)BR rats, in compliance with OECD Guideline No.: 402.

A limit test was carried out at 2000 mg/kg body weight (bw) in 5 male and 5 female rats (7 to 8 weeks of age). The test item was applied as supplied, moistened with distilled water, as a single dermal 24-hour exposure followed by a 14-day observation period.

Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing and weekly thereafter. Rats were euthanized and necropsied at the end of the 2-week observation period (Day 14).

The results of the study were summarized as follows:

No mortality occurred.

No clinical signs were observed after the treatment with the test item or during the 14 day observation period.

After treatment with DYNS 2246, purple staining of the treated area was observed up to and including Day 8.

Body weight and body weight gain of DYNS 2246-treated animals did not show any test item related effect.

No test article-related macroscopic finding occurred.

Conclusions

Under the experimental conditions described in this report, the acute dermal median lethal dose (LD₅₀) of the test item DYNS 2246 was higher than 2000 mg/kg body weight in male and female CRL:(WI) BR rats.