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

Endpoint summary

Description of key information

Oral (OECD 401), rat (m/f): LD50 > 5000 mg/kg bw (limit test), based on read-across
Dermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test), based on read-across

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The available information comprises adequate and reliable studies (Klimisch score 2) from reference substances with similar structure and intrinsic properties.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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

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.

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.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties.

Additional information

There is no data available on the acute toxicity of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substance is conducted.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

Oral

No data is available on the acute oral toxicity of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). However, there are reliable studies on the structurally related substances D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, Decyl glucoside, hexadecan-1-ol (CAS 36653-82-4) and octadecan-1-ol (CAS 112-92-5), the first two also being members of the category, the latter two being structurally related analogues even present in the substance D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) itself.

Acute oral toxicity studies with the alcohols hexadecan-1-ol and octadecan-1-ol in male and female Sprague Dawley rats at a limit dose of 2000 mg/kg bw were performed according to OECD guideline 401 and in compliance with GLP (SafePharm, 1996a and b). No mortality and no adverse effects were observed up to the end of the 14-day observation period. Based on these results, the oral LD50 value for rats was greater than 2000 mg/kg bw.

A further GLP-study on the acute oral toxicity study in male and female Sprague Dawley rats, equivalent or similar to OECD guideline 401, is available for the category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (Hill Top Biolabs, 1990). No mortality and no adverse effects were observed up to the end of the 14-day observation period. Based on the results of the study, the oral LD50 value for rats was greater than 5000 mg/kg bw.

No mortality and no acute toxic effects were observed in a study with Decyl glucoside, either, from which an oral LD50 value for rats greater than 5000 mg/kg bw was derived (BASF, 1982).

Dermal

No data are available on the acute dermal toxicity of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). However, one reliable GLP-study according to OECD guideline 402 with the structurally related category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides exists, which is used for read-across based on the category approach.

In the acute dermal toxicity study with D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, the test substance was applied at a limit dose of 2000 mg/kg bw on the skin of 5 male and female New Zealand White rabbits for 24 h. Clinical signs of partly hunched posture and slight depression occurred during the observation period. No mortality and no adverse effects including those on the skin were observed during the study period. Therefore, the dermal LD50 value of the test substance for male and female rabbits was greater than 2000 mg/kg bw (Hill Top Biolabs, 1989).

Inhalation

This information is not available. The substance has a low vapour pressure and is marketed in granules of a size excluding the possibility of inhalation; experience demonstrates that no dust formation occurs upon handling. Therefore, exposure to vapours or dusts is not to be expected. In addition, reliable data from studies for acute toxicity via the oral and the dermal route performed with structurally related substances according to Regulation (EC) No. 1907/2006, Annex XI, article 1.5 are available.

Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across based on a category approach/read-across from a structural analogue and weight of evidence from these studies.

Justification for selection of acute toxicity – inhalation endpoint
No study required since the substance has a low vapour pressure and is marketed in granules of a size excluding the possibility of inhalation; experience demonstrates that no dust formation occurs upon handling. Therefore, human exposure to vapours or dusts is not to be expected.

Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across based on a category approach. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Justification for classification or non-classification

The available data on the acute toxicity of substances structurally related to D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) according to Regulation (EC) No 1907/2006, Annex XI, 1.5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC; therefore, D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) is not expected to exert acute toxicity, either, and the data are thus conclusive but not sufficient for classification.