Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
May 3 to 17, 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 the substance is not toxic. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts ) was used as supporting substance due to the structural analogy. They are both in the category 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 sub-categories 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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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
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.