Blue MGi 1037-Na (notification presscake)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69, B.3

Version / remarks:

1992

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Switzerland
- Age at study initiation: 10 weeks (males), 12 weeks (females)
- Weight at study initiation: males: 254.3-266.9 g / females: 191.7 -211.2g
- Housing: individually in Makrolon type-3 cages
- Diet: ad libitum, pelleted standard Kliba 3433
- Water: ad libitum, tap water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 35-57
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

Bidistilled water

Details on dermal exposure:

TEST SITE
- % coverage: 10
- Type of wrap: semi-occlusive dressing fixed with an elastic adhesive bandage

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: test day 1,8, and 15 (weighting) and 1,2,3,5 hours, day 1 and twice daily on days 2-15 (mortality/viability)
- Necropsy of survivors performed: yes
- Clinical signs including body weight : yes

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 deaths occured during the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the study period.

Gross pathology:

Effects on organs:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a study performed with Blue MGi 1037 in rats the LD50 was >2000 mg/kg bw.

Executive summary:

A group of five male and five female rats was treated with the substance Blue MGi 1037 at 2000 mg/kg by dermal application. The test item was suspended in bi-distilled water at a concentration of 0.5 g/mL and administered at a volume of 4 mL/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study. No clinical signs were observed during the observation period. Slight focal erythema were observed in 3 male and 3 female animals on test day 2 after removal of the dressing and persisted in 2 male animals until test day 5 and in 2 female animals until test days 3 and 4, respectively. Two female showed a marginal loss of body weight (1.7 and 1.8 %) one week after treatment. The body weight of the other animals was within the range commonly recorded for animals of this strain and age. No macroscopic findings were observed at necropsy.

The median lethal dose of the substance after single dermal administration to rats of both sexes, observed over a period of 14 days (LD50) is greater than 2000 mg/kg body weight.