Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with citric acid, disodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 28, 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The acute oral toxicity test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that thes ubstance is not toxic.. The alkylpolyglucoside has a carbon chain length range of C10-C14. They are both in thecategory of the long linear and branched chain alcohols. Key points are that the members share the same structural features, similar metabolic pathways, common mode of ecotoxicological action and common levels and mode of human health related effects. Member of the long chain alcohols are of a low order of toxicity following acute and repeated exposures. The overall toxicological profile of the subcategories of linear and essentially linear alcohols is qualitatively and quantitatively similar for all end points. Reference: OECD SIDS Long chain alcohols, April 18-21, 2006.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Principles of method if other than guideline:

The dose has been choosen in according with EEC directive 67/548.
References:
- OECD Short-term and Long-term toxicology groups.
- WHO pubblication: Environmental Health criteria 6, Principles and method for evaluating the toxicity of chemicals, part 1, Geneva 1979

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with citric acid, disodium salts

IUPAC Name:

Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with citric acid, disodium salts

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: "Morini" - S.Polo d'Enza, Italy
- Weight at study initiation: 140-200 g
- Fasting period before study: pellet complete diet
- Housing: transparent polycarbonate cages of mm 425 x 266 x 180
- Water : filtered water from local network
- acclimation: at least 1 week before the start of the test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.+/- 2 °C
- Humidity (%): 55 +/- 15 %
- Air changes (per hr): 25 times
- Photoperiod (hrs dark / hrs light): 12h/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days at frequent intervals during the first day and then daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Key result

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no animals died

Clinical signs:

Slight piloerection in male rats no. 1, 3, 4, 5 and female rats no. 4, 5. This symptomatology is disappeared after 9 day from begining the study.

Body weight:

Normal

Gross pathology:

Slight mucosa enteritis in male rats n.1, 3

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was higher than 5000 mg/kg; no classification is required.