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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 - 25 Feb 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
D-Glucopyranose, oligomers, decyl octyl glycosides
EC Number:
500-220-1
EC Name:
D-Glucopyranose, oligomers, decyl octyl glycosides
Cas Number:
68515-73-1
Molecular formula:
Not applicable: UVCB
IUPAC Name:
D-Glucopyranose, oligomeric, C8-10 glycosides
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: brown liquid
- Analytical purity: No data
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm
- Weight at study initiation:2536-2979 g (males), 2528-2847 g (females)
- Housing: individually in wire mesh suspension cages
- Diet: Purina Laboratory Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Feb 1987 To: 25 Feb 1987

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: the test material was introduced into the sleeve of a rubber dental dam, which was wrapped around the trunk and secured with staples. An outer layer of gauze was placed on the trunk and fixed with tapes.


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for gross signs of systemic toxicity once on the day of treatment and then twice during the 14-day observation period. Body weights were determined on the day of treatment (Day 0), and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal irritation, histopathology of unscheduled death
Statistics:
Mean values and standard deviations of body weights were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female died during the observation period (on Day 13).
Clinical signs:
other: Clinical changes associated with the test material were as follows: 1. Faecal stains 2. Yellow area throughout the site 3. Emaciated (2 animals) 4. Nasal discharge (3 animals) 5. Lacrimation (1 animal)
Gross pathology:
A gross necropsy performed on the animal which died revealed the following:
1. Faecal stains
2. Discharge from the nose and mouth
3. Lungs appeared reddened
4. Spleen appeared darkened
5. Stomach appeared white
6. Liver covered with an excessive amount of white spots

In 5 of 9 surviving animals, a spotty area of haemorrhage was observed on the lungs at necropsy.
Other findings:
- Histopathology: microscopic examination of the animal which died on Day 13 confirmed the Tyzzer's disease as cause of death.
- Other observations: the most frequently observed irritative effects were as follows:
1. mild to marked erythema
2. mild to moderate oedema
3. mild to moderate atonia
4. mild to moderate desquamation
5. mild coriaceousness

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified