Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2002-09-18 to 2003-03-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed accordingly to the OECD Guideline No. 402 and in compliance with the GLP. Moreover, the information on the test substance is available.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Curb Powder, Aluminium ammonium sulfate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding Facility, Jai Research Foundation, India
- Age at study initiation: 10 weeks old at the time of dosing
- Weight at study initiation: 235 to 289 g
- Fasting period before study: No data
- Housing: 3 animals per cage in polypropylene cages covered with stainless steel grid top. Autoclaved clean rice husk was used as the bedding material.
- Diet (e.g. ad libitum): ad libitum; rat pellet diet (Amrut brand) manufactured by Pranav Agro Industries Limited, Pune, Mahashtra, India
- Water (e.g. ad libitum): ad libitum in a polypropylene water bottle with a stainless steel nozzle. The drinking water was filtered through Aquagard water filter system.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 25 °C
- Humidity (%): 67%
- Air changes (per hr): 18 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h artificial light / 12 h darkness

IN-LIFE DATES: From 2002-10-26 to 2002-11-15

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
distilled
Details on dermal exposure:
TEST SITE
- Area of exposure: Hair were closely clipped from the dorsal area of the trunk of each animal, 24 hours prior to treatment.
- % coverage: 10% of the body surface area
- Type of wrap if used: porous gauze dressing and Medi tape 330 hypo-allergic surgical tape (manufactured by JMS Co. Ltd., Hiroshima 730, Japan).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residual test substance was remove using cotton moistened with distilled water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The quantities of Aluminium ammonium sulfate powder moistened with distilled water were calculated for each animals
- Concentration (if solution): no data
- Constant volume or concentration used: no
- For solids, paste formed: not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): not required
- Purity: no data
Duration of exposure:
24 hours
Doses:
2000 mg / kg bw
No. of animals per sex per dose:
See table 7.2.3/1
Two groups: 0 mg / kg bw (control group) and 2000 mg / kg bw
Five males and five females per group
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at 1, 2, 3 and 5 hours after the treatment, and then daily for 14 days. Individual body weights were recorded prior the treatment (day 0) and on days 7 and 14 after treatment.
- Necropsy of survivors performed: yes, gross pathological examination (external examination and internal examination of abdominal and thoracic cavities).
- Other examinations performed: clinical signs, body weight
Statistics:
No data

Results and discussion

Preliminary study:
A dose range-finding study for Aluminium ammonium sulfate powder was performed using four animals ( 2males and 2 females) per group at dose levels of 2000 and 2500 mg / kg bw. No mortality was observed neither at 2000 mg / kg bw nor at 2500 mg / kg bw. Therefore, the main study was conducted as a limit study at the dos level of 2000 mg / kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed in the control group as well as the group treated with Aluminium ammonium sulfate at the dose level of 2000 mg / kg bw.
Clinical signs:
No clinical signs were observed in the control group as well as the treated group.
Body weight:
The mean body weight of animals treated with Aluminium ammonium sulfate was comparable to that of the control group animals.
See table 7.2.3/2
Gross pathology:
External examination of animals belonging to the control and the treatment groups did not reveal any abnormality or lesion of pathological significance.
Internal examination of animals belonging to the control and the treatment groups revealed lesions in lungs (haemorrhage, consolidation / hepatisation / pneumonic foci); spleen (enlarge) and kidneys (congestion).
The above recorded lesions were unrelated with the test substance and could be considered as spontaneous / incidental findings.
Other findings:
No additional findings

Any other information on results incl. tables

Table 7.2.3/2: Group mean body weight

Group

Dose of Aluminium ammonium sulfate

(mg / kg bw)

Sex

Mean Body Weights (g)

Mean Per cent Body Weight Change

day 0

day 7

day 14

day 7

day 14

I

0

(Control)

5 males

267 ±14

299 ± 13

332 ± 15

12.0 ± 1.7

24.6 ± 3.7

5 females

242 ± 4

247 ± 6

258 ± 6

2.2 ± 2.9

6.7 ± 1.9

II

2000

5 males

271 ± 11

293 ± 12

327 ± 11

8.0 ± 0.6

20.6 ± 3.5

5 females

243 ± 5

250 ± 7

258 ± 12

3.0 ± 1.3

6.4 ± 3.9

Values are mean ± standard deviation

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, aluminium ammonium sulfate is not classified according to the criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.
Executive summary:

In an acute dermal toxicity study, Aluminium ammonium sulfate was applied by dermal way to 10 males and females Wistar rats at dose levels of 0 (negative control) and 2000 mg/kg bw. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 402 (Acute Dermal Toxicity).

A range-finding study was preliminary performed to determine the limit dose for the main study. Therefore, the main study was conducted as a limit study at the dos level of 2000 mg / kg bw.

The rats were observed for mortality and overt signs of toxicity at 1, 2, 3 and 5 hours after the test substance application. Subsequently, the animals were observed for a period of 14 days following dermal application. Individual body weights were recorded prior to dermal application (day 0) and on days 7 and 14 following dermal application. At the end of the 14 days observation period, all the animals were euthanised and subjected to gross pathological examination.

No clinical signs, no significant changes in the body weight and no mortality were observed in the treated group (2000 mg / kg bw) in comparaison with the control group. The external and internal examinations revealed no abnormality due to the test substance.

The acute dermal lethal dose (LD50) of aluminium ammonium sulfate in rats is higher than 2000 mg / kg bw.

Under the test conditions, aluminium ammonium sulfate is not classified according to criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.