NALCO 73280

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 April 2002 to 01 May 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with International Guidelines and in accordance with the principles of Good Laboratory Practise (GLP).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): NALCO 01WC026 / PSO
- Lot/batch No.:XC1M0642

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx 8 weeks old
- Weight at study initiation: Males 277 - 320g, Females 205 - 217 g
- Fasting period before study: None
- Housing: Individually housed in labelled Macrolon cages containing purified sawdust as bedding
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet from Altromin (code VRF 1) Lage, Germany.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 day before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: One day before exposure an area of approximately 5 x 7 cm on the back of the animal was clipped.
- % coverage: approx 10% of total body surface
- Type of wrap if used: surgical gauze coveed with aluminium foil and coban flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24 hours contact period the dressings were removed and the skin cleaned of residual test substance using water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dose level 2000mg/kg (1.47 ml/kg) bodyweight
-Specific gravity : 1.36
- Constant volume or concentration used: yes


VEHICLE - not applicable, test material used as supplied:

Duration of exposure:

24 hour contact period

Doses:

2000mg/kg (1.47 ml/kg) bodyweight

No. of animals per sex per dose:

5 Males and 5 Females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed immediately after dosing and at 2 and 4hours after dosing for signs of toxicity/ death and thereafter once daily (twice daily for mortality) for 14 days.Individual bodyweights were recorded on day 1 prior to dosing and on days 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred

Mortality:

There were no deaths.

Clinical signs:

other: Lethargy was noted in two males on days 1 and / or 2. No other signs of systemic toxicity were observed in the remaining animals. Erythema, scales and / or scabs were seen in the treated skin area of the animals during the observation period. Individual

Gross pathology:

No test substance related abnormalities were found at macroscopic post mortem examination of the animals.
Individual macroscopic observations are given in table 3 See attached file S7.2.3 Acute toxicity dermal results tables 1 - 3.pdf

Any other information on results incl. tables

Please refer to attached file S7.2.3 Acute toxicity dermal results tables 1 - 3.pdf for:

Table 1 - Individual clinical signs

Table 2 - Individual bodyweights

Table 3 - Individual macroscopic observations

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of the test substance in Wistar rats was found to be greater than 2000mg/kg bodyweight

Executive summary:

The study was performed to assess the acute dermal toxicity of the test substance in the Wistar rat. The study was carried out based on the guidelines EEC Directive 92/69 EEC, B.3 "Acute Toxicity Dermal" and OECD Guideline no. 402 "Acute Dermal Toxicity"

Method

Five male and five female Wistar rats were given a single 24 hour, semi occluded dermal appliaction of the undiluted test substance to clipped intact skin at a dose level of 2000 mg/kg bodyweight. Animals were monitored for clinical signs, bodweights were determined weekly and a full macroscopic examination was performed after terminal sacrifice.

Mortality

There were no deaths.

Clinical signs

Lethargy was noted in two males on days 1 and / or 2. No other signs of systemic toxicity were observed in the remaining animals.

Erythema, scales and / or scabs were seen in the treated skin area of the animals during the observation period.

Bodyweight

Animals showed expected bodweight gains over the study period.

Necropsy

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