Reaction products of diazotized Dodecyl Aniline coupled with 8-acetylamine-1-hydroxynaphthalen-3,6-disulphonic Acid, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2017-04-13 to 2017-05-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

disodium 3-[(1E)-2-(4-dodecylphenyl)diazen-1-yl]-5-acetamido-4-hydroxynaphthalene-2,7-disulfonate

EC Number:

946-819-5

Molecular formula:

Not applicable for UVCB substance

IUPAC Name:

disodium 3-[(1E)-2-(4-dodecylphenyl)diazen-1-yl]-5-acetamido-4-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Hsd

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Envigo RMS s.r.l., San Pietro al Natisone (UD), Italy
-Females nulliparous and non-pregnant: yes
-Age at study initiation: 7 weeks old
-Weight at study initiation: 168.3-189.3 grams
-Fasting period before study: food was removed from the cages overnight prior to dosing (Day -1) and was made available approximately 4 hours after dosing.
-Animals per cage 3 during the study; up to 5 during acclimatisation
-Housing: Polisulphone solid bottomed cages measuring 59.5×38×20 cm with nesting material provided into suitable bedding bags
-Diet :4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy) ad libitum
-Water: drinking water supplied to each cage via a water bottle ad libitum
-Acclimation period: At least 5 days
-Veterinary health check: During acclimatisation period

ENVIRONMENTAL CONDITIONS
-Temperature: 22 °C ± 2 °C
-Humidity: 55 % ± 15 %
-Air changes: Approximately 15 to 20 air changes per hour
-Photoperiod: Artifi cial (fl uorescent tubes), daily light /dark cycle of 12/12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
-Amount of vehicle: the formulated test item was administered at a dose volume of 10 ml/kg using a plastic feeding tube attached to a graded syringe.

Doses:

300, 2000 mg/kg b.w

No. of animals per sex per dose:

Step 1: 3 females at 300 mg/kg b.w
Step 2: 3 females at 300 mg/kg b.w
Step 3: 3 females at 2000 mg/kg b.w
Step 4: 3 females at 2000 mg/kg b.w

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observation mortality and morbidity: throughout the study, all animals were checked twice daily.
-Frequency of observations:
Animals were observed for clinical signs as indicated below:
Day of dosing:
· Session 1: on dosing
· Session 2: approximately 0.5 hour after dosing
· Session 3: approximately 2 hours after dosing
· Session 4: approximately 4 hours after dosing
Daily thereafter for a total of 14 days
-Frequency of and weighing: all animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
-Necropsy of survivors performed: yes, all animals were sacrificed by carbon dioxide narcosis.
Necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the gastro-intestinal tract).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: Only violet faeces in cage were observed at 4 hours after dosing in the first group of animals initially dosed at 300 mg /kg (Group 2, Step 1). In addition, violet staining in cage was recorded at 4 hours after dosing. In the secondo group at the same dos

Gross pathology:

No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups receiving 300 mg/kg and only red staining on the tail was observed in all animals dosed at 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according the CLP Regulation (EC 1272/2008)

Conclusions:

The acute toxicity expected (ATE) of the test item was found to be greater than 2000 mg/kg body weight.

Executive summary:

The acute toxicity of test item was investigated following a single oral administration to the Sprague Dawley rat, followed by a 14-day observation period. The test was performed according to the OECD 423 (2001). Two groups, each of 3 female animals, were initially dosed at 300 mg /kg. A third group, similarly composed, was dosed at 2000 mg/kg. A fourth group of 3 female animals was administered at the same dose level.

No mortality occurred at any dose levels. Only violet faeces in cage were observed at 4 hours after dosing in one group at dose 300 mg/kg bw; in the other group at same dose no clinical signs were noted. In one group at dose 2000 mg/kg bw red staining on the tail and on perigenital region in all animals was observed from Day 2 up to Day 15 of the observation period. In the other group at same dose only red staining on the tail in all animals was seen for the entire observation period. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups receiving 300 mg/kg and only red staining on the tail was observed in all animals dosed at 2000 mg/kg.

These results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.