Alcohols, C16-18, reaction products with D-glucose

Acute Toxicity: dermal

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-Glycopyranose, oligometric, C10-16-alkyl glycosides (CAS 110615-47-9). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, 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:

1989

Report date:

1989

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

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

110615-47-9

Molecular formula:

C6H11O5-(C6H10O5)[m-1]-O-(CH2)[n-1]-CH3 (m=1 to 10; n=10 to 16)

Details on test material:

- Name of test material (as cited in study report): trade name
- Physical state: golden pale viscous liquid
- Analytical purity: no data
- Storage condition: 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, USA
- Weight at study initiation: 2870-2915 g (males), 2746-3057 g (females)
- Housing: individually in suspension cages with wire mesh floors
- 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:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: the test substance was held in contact with the skin using a porous gauze dressing secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed with a moistened towel.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw: 4.9-5.1 mL (males) and 4.8- 5.3 mL (females)
- Dose factor: 1.74 mL/kg

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 daily for signs of toxicity and behavioural changes. Individual body weights were determined prior to treatment, on Day 7 and prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

For body weights, mean values and standard deviations 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:

No deaths occurred.

Clinical signs:

other: Partly hunched posture and slight depression occurred during the observation period.

Gross pathology:

No treatment-related changes.

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