Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2011-12-06 to 2011-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - FRANCE)
- Age at study initiation: MALE: 8 weeks old. FEMALE: 9 weeks old
- Weight at study initiation: MALE : from 265 g to 290 g. FEMALE: from 210 g to 242 g
- Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5, in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): ad libitum (foodstuff: M20-SDS)
- Water (e.g. ad libitum): ad libitum (tap water from public distribution system)
- Acclimation period: of at least five days

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
paraffin oil
Details on dermal exposure:
TEST SITE
- Area of exposure:dorsal area of the trunk
- % coverage: at least 10% of the body surface cleared for the application of the test item
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with liquid paraffin
- Time after start of exposure: After 24 hours exposure period

TEST MATERIAL
- Concentration (if solution): 2000 mg/L
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICULE
Duration of exposure:
Exposure period of 24 hours
Doses:
Group 1: 2000 mg/kg
Group 2: 2000 mg/kg
No. of animals per sex per dose:
Group 1: 5 male rats
Group 2: 5 female rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily examination (spontaneous activity, preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance). Weighing on days D0 (before administration of th test item), D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examinations at the end of the study (after anaesthesia) with the examination of organs likely to be modified in cases of acute toxicity (oesophagus, stomach, the entire digestiv tract, spleen, liver, thymus, trachea, lungs, heart, kidneyx, urinary bladder, testicules, skin of the treatment area, adrenals, pancreas).

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study
Clinical signs:
No clinical sign was observed. A slight black coloration of the treatment site was noted in all animals on D1.
Body weight:
The body weight evolution of the animals remained normal throughout the study by comparison with the control animals standing in the same environment.
Gross pathology:
No gross pathology was observed.

Any other information on results incl. tables

Current control study: The study identified TAD-PH-11/0623 was performed to assess the behaviour of the strain of rat used at this laboratory in its environment and to give additional historical data. The study was performed from 25 October 2011 to 08 November 2011.

the method was designed to meet the requirements of the following: OECED guideline for the testing of chemicals N°402 dated February 24thn, 1987 and the method B3 of the Council regulation N°440/2008.

Test item: Liquid paraffin

METHODS:

Ten aminals, five males and five females, received by topical administration, an effective dose of 10 ml/kg body weight of the control item liquid paraffin, under porous gauze dressing, during 24 hours.

RESULTS:

Clinical examinations: Nothing to report. Animal normal (10/10)

Bodyweight evolution: Normal throught the study

Necropsy: No treatment related changes were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item Solvent Black 46 is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.
According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item Solvent Black 46 must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.
Executive summary:

The test item Solvent Black 46 was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3. of the Council regulation n°440/2008 of 30 May 2008.

No mortality occured during the study.

No systemic clinical sign related to the administration of the test item was observed. A slight black coloration of the treatment site was noted in all animals on day 1.

The body weight evolution of the animals remained normal throughout the study.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item Solvent Black 46 is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.

According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item Solvent Black 46 must not be classified. No symbol or risk phrase is required.

In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.