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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study tested with the source substance D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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
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
Test material form:
other: liquid, not further specified
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

Administration / exposure

Type of coverage:
occlusive
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 atopy
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