Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 - 19 May 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Guidance 84/449/EWG (1984)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

276-374-6

EC Name:

Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

72139-17-4

Molecular formula:

C25H16ClF2N5O8S2.2Na

IUPAC Name:

disodium 1-amino-4-({3-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-methyl-5-sulfophenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid

Details on test material:

Reactive Blue 114

Test animals

Species:

rat

Strain:

Wistar

Remarks:

WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: male: approx. 9 weeks, female: approx. 14 weeks
- Weight at study initiation: male: mean 205g, female: mean 184g
- Fasting period before study: NA
- Housing: single
- Diet (e.g. ad libitum): Altromin (R) 1324 pellets, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): aprox. 50 +/- 10%
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 10% of body surface area
- Type of wrap if used: treated area covered with aluminum foil and fixed with patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: approx. 24h after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5ml/ kg bw
- Constant volume or concentration used: NA, limit dose

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: before application, after 1 week and after 14 days, observations: multiple observation on day of application, afterwards twice a day on working days, once on weekend
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred

Clinical signs:

no clinical signs observed

Body weight:

body weight was not affected

Gross pathology:

macroscopic normal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 to male and female rats was determined to be > 2000 mg/kg bw. The substance is not classifiable according to CLP criteria.