Reaction products of 7-amino-4-hydroxynaphthalene-2-sulfonic acid reacted with 2-((1,3,5-triazin-2-yl)amino)ethan-1-ol, coupled with diazotised 3-amino-4-hydroxybenzenesulfonic acid, subsequently coupled with diazotised 2-amino-5-methoxybenzenesulfonic acid, chelated with copper, sodium salt

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-05-20 to 1991-06-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

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

Test material form:

solid: particulate/powder

Details on test material:

Direct Red 83:1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Sprague-Dawley strain rat (Safepharm Definitive Protocol Number TX 3074)
10 fasted animals
5 males (254 – 275 g)
5 females (203 – 225 g)
Approx. 10 – 14 weeks old
Minimum of 5 days acclimatisation period
The animals were housed individually in solid-floor polypropylene cages during the 24-hour exposed period. For the remainder of the study,
The animals were housed in group of five by sex in solid floor polypropylene grid-floor cages suspended over trays lined with absorbent paper. Free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 18-23 °C; on one occasion the temperature was outside the lower limit specified in the protocol (19°C); but this did not affect the purpose or integrity of the study. The relative humidity was 50-61%.
The rate of air exchange was approx. 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

PROCEDURE:
On the day before treatment the back and the flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approx. 5cm x4 cm.
A group of five males and five females’ rats were treated with KAYARUS SUPRA RUBINE BLN at a dose level of 2000 mg/kg
The appropriate amount of the undiluted test material, as received, was pre-weighed into a glass vial and applied uniformly to an area of shorn skin (approx. 10% of the total body surface area)
Which had been previously been moistened with arachid oil B.P.
A piece of surgical gauze was placed over the treatment area semi-occlude with a piece of self adhesive bandage (HYPERTIE).
The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24 hour exposure period.
Shortly after dosing the dressing were examined to ensure that they were securely removed and the treated skin and surrounding hair wiped with cotton wool moistened with acetone to remove any residual test material.

Duration of exposure:

24 h

Doses:

2000mg/kg bodyweight

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
No deaths.
No signs of systemic toxicity or skin irritation were noted during the study. Purple-coloured staining was noted at all treatment sites one day after treatment. Residual test material was noted on the treatment sites up to four days after treatment.
No toxicologically significant effects on bodyweight
No abnormalities at necropsy

Statistics:

DATA EVALUATION:
Data evaluation included the relationship if any, between the animals’ exposure of the test material and the incidence of severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained and estimate according to the acute dermal median dose (LD50) of the test material was made.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: No signs of systemic toxicity or skin irritation were noted during the study. Purple-coloured staining was noted at all treatment sites one day after treatment.

Gross pathology:

none

Other findings:

OTHER OBSERVATION:
Residual test material was noted on the treatment sites up to four days after treatment.

Any other information on results incl. tables

No deaths,

No signs of systemic toxicity,

All animals showed expected gain in bodyweight

No abnormalities at necropsy

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the acute dermal lethal median dose (LD50) of Direct Red 83:1 in the Sprague-Dawley strain Rat was found to be greater than 2000 mg/kg bodyweight
-No symbol and risk phrase are required according to CLP labelling regulations

Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat.

A group of ten fasted animals (five males and five females) was given a single 24 hour, semi-occluded dermal application to intact skin at a dose level 2000 mg/kg bodyweight.

The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.

-There were no deaths. No signs of systemic toxicity were noted during the study.

-All animals showed expected gain in bodyweight during the study; i.e. after assessment of individual as well as weekly bodyweight increase, no toxicologically significant effects on bodyweight were noted during the study.

-No abnormalities were noted necropsy.

Hence, under the test conditions, the acute dermal median lethal dose (LD₅₀) of Direct Red 83:1 in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight

Species	Strain	Origin	Sex of animals dosed	Tabulation of response data by dose level	LD50 Value	Findings
Sprague Dawley rats	HSD: Sprague Dawley SD	Charles River (U.K.) Ltd., Manston, Kent. U.K.	Male and female	No animals died during the test.	>2000	-No signs of systemic toxicity or skin irritation were noted during the study. Purple-coloured staining was noted at all treatment sites one day after treatment. -All animals showed expected gain in bodyweight during the study -No abnormalities were noted necropsy.