6-deoxy-L-mannose

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:

2016

Report date:

2016

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:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Japan Test Guidelines for Agricultural Chemicals 12-Nousan-8147 (2000)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-deoxy-L-mannose

EC Number:

222-793-4

EC Name:

6-deoxy-L-mannose

Cas Number:

3615-41-6

Molecular formula:

C6H12O5

IUPAC Name:

6-deoxy-L-mannose

Test material form:

other: crystalline powder

Details on test material:

- Purity: 98%

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 299.0-327.9 g (males); 213.2-226-8 g (females)
- Fasting period before study: No
- Housing: Individually in solid-bottom caging with bedding and appropriate species-specific enrichment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C) :20-26ºC (68-79ºF)
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): approximate 12-hour light/dark cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 37 square centimeters
- % coverage: approximately 10 percent of the total body surface area of rats in the 200 - 300 g body weight range
- Type of wrap if used: 2-ply gauze patch. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with paper towels soaked in warm water
- Time after start of exposure: Approximately 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg of body weight
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

5000 mg/kg

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: The rats were weighed on test days 1, 8, and 15, and were observed daily for clinical signs of toxicity and dermal irritation (weekends and holidays excluded for dermal irritation). The rats were reshaved as needed during the study.
- Necropsy of survivors performed: yes

Statistics:

Not applicable

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: highest dose tested

Mortality:

There were no incidents of mortality.

Clinical signs:

other: One male exhibited scabbing on the back (inside of the test site) between test days 6-15 and discolored skin on the back between test days 6-7. Between test days 12-15, a wound on the right shoulder was observed in one male. Epidermal scaling (inside the

Gross pathology:

Gross findings were present in 2/5 male animals, which correspond to the clinical observations noted above. One male had a skin ulcer/erosion present on the back at the outer edge of the treated skin area. The other male had a single skin ulcer/erosion present on the right shoulder. No other gross findings were observed.

Other findings:

There were no instances of edema or erythema observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rats): >5000 mg/kg

Executive summary:

A single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose level of 5000 mg/kg of body weight. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage at the end of the 15-day test period.

There were no incidents of mortality and no overall (test day 1-15) body weight losses among any animals. One male exhibited scabbing on the back (inside of the test site) between test days 6-15 and discoloured skin on the back between test days 6-7. Between test days 12-15, a wound on the right shoulder was observed in one male. Epidermal scaling (inside the test site) was noted in one female between test days 6-8. No other clinical abnormalities were observed. There were no instances of oedema or erythema observed. Gross findings were present in 2/5 male animals, which correspond to the clinical observations noted above. One male had a skin ulcer/erosion present on the back at the outer edge of the treated skin area. The other male had a single skin ulcer/erosion present on the right shoulder. No other gross findings were observed. Under the conditions of this study, the dermal LD₅₀ for the test substance was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.