Ammonium fluoride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

26 april to 13 may 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed according to test guidelines and GLP

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium chloride

EC Number:

235-186-4

EC Name:

Ammonium chloride

Cas Number:

12125-02-9

IUPAC Name:

ammonium chloride

Details on test material:

- Name of test material (as cited in study report): Ammonium Chloride
- Physical state: White solid powder
- Analytical purity: 99.7% (w/w)
- Impurities (identity and concentrations): Asche 0.25%, NaCl 0.2%, H20 0.1% (at maximum)
- Lot/batch No.: 30262868EO
- Expiration date of the lot/batch: Not indicated
- Stability under test conditions: Not indicated
- Storage condition of test material: Room temperature, in metal container

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: VELAZ s.r.o, Kolec u Kladna, Czech Republic
- Age at study initiation: Not indicated
- Weight at study initiation: Males: 267-291 g; Females: 167-204 g
- Fasting period before study: No
- Housing: One animal in one plastic cage
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26 April 2010 To: 13 May 2010

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10% of the body surface
- Type of wrap if used: Application site covered by mull and held in place by plaster (strapping)

REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: No

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

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: Daily observations, weighing before application and on days 8 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: Macroscopic abnormalities at necropsy

Statistics:

No

Results and discussion

Preliminary study:

Preliminary study performed with 1 male and 1 female at 2000 mg/kg body weight. Slight irritation of treated skin in the female on days 2-4 after application

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Slight irritation of treated skin in 1 female on days 2-4 after application

Gross pathology:

No macroscopic abnormalities

Other findings:

No

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material at 2000 mg/kg body weight caused transient irritation in one of five females. There is no need to classify or label the test material for acute dermal toxicity.