7-anilino-4-hydroxy-3-[[6-methoxy-4-[(6-sulpho-2,4-xylyl)azo]-m-tolyl]azo]naphthalene-2-sulphonic acid, sodium salt, compound with 2,2',2''-nitrilotriethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

key study

Study period:

29 March 2017 to 28 April 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

As the acute oral LD50 leads to classification, the acute dermal study cannot be waived.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain; RccHan:WIST
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Females nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 255-275 g; females 201-236 g
- Fasting period before study: none
- Housing: 1 male+ 1 females individually; 4 males + 4 females individually during exposure and 4/sex per cage during the rest of the test period in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: ca 10% of body surface
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes wiped with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied:2000 mg/kg bw (moistened with distilled water)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1 male + 1 female followed by 4 males + 4 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days (includes signs of irritation)
- Bodyweight: on day 1 7 and 14
- Necropsy of survivors performed: yes

Statistics:

NA

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:

none

Clinical signs:

none

Body weight:

one female did not gain weight

Gross pathology:

no findings

Other findings:

No irritation observed. All animals showed staining of the skin at the test site up to day 4 and one female with scabs

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The LD50 of the substance is > 2000 mg/kg bw

Executive summary:

In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 2000 mg/kg bw.