Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 - 30 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No 8147, April 2011; including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

EC Number:

274-986-8

EC Name:

Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

Cas Number:

70892-34-1

Molecular formula:

not applicable

IUPAC Name:

Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

Test material form:

other: wet presscake

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (males: 287 grams; females: 190 grams).
- Housing: Individual housing in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle.

IN-LIFE DATES: From: 16 - 30 August 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.

The test substance was weighed directly on a surgical gauze patch (Surgy 1D)* (4-ply ; 5 x 5 cm for males and 5 x 3.5 cm for females) at 1 decimal precision and dispersed over the patch as equally as possible. The application area was approximately 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The weight of test substance to be applied was based on the animals’ individual body weight. The test substance was weighed first for males and released for dosing, and subsequently for females. The patch was mounted on aluminium foil which in turn was mounted on Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore).

Frequency: Single dosage, on Day 1.

Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg (based on main component C.I. Leuco Sulphur Brown 37). This dose corresponded to 14815 mg test substance including C.I. Leuco Sulphur Brown 37, based on a correction factor calculated as 100/13.5 (to correct for purity of the test substance).

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none.

Statistics:

None.

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:

other: see "Remark"

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 value of C.I. Leuco Sulphur Brown 37 in Wistar rats was established to exceed 2000 mg/kg body weight (based on main component Leuco Sulphur Brown 37, corresponding to 14815 mg test substance including C.I. Leuco Sulphur Brown 37/kg body weight.