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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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. 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:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 Dec 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Sécrétariat général du GIPC, Paris, France
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trade name given
- Substance type: tenside
- Physical state: yellow liquid
- Analytical purity: 49.8% solid content
- Purity test date: 15 Apr 2007
- Lot/batch No.: T71531
- Stability under test conditions: responsibility of sponsor
- Storage condition of test material: room temperature
- Other: pH 5.6

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 190-202 g
- Fasting period before study: food removed on day before until 4 hours after test item administration
- Housing: groups of 3 in solid-bottomed clear polycarbonate cages with stainless steel mesh lid. Each cage contained sawdust bedding which was changed at least 2 times a week.
- Diet: pelleted M20 rat/mouse maintenance diet (EXTRALABO from PIETREMENT), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 32-62
- Air changes (per hr): conventional air-conditioned, not further specified
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Amount of vehicle: 2 mL/kg bw water for control group

MAXIMUM DOSE VOLUME APPLIED: 1.69 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 min, 1 hour, 3 and 4 hours after dosing and daily thereafter for mortality and behavioural or toxic effects on the major physiological functions (spontaneous activity), Preyer's reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance. These observations were compared to control data. Weighing was done on Day 0 just before administration and on Days 2, 7, and 14. Weight changes were calculated and recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: gross pathological changes of esophagus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 experimental
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs related to test item administration were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Any other information on results incl. tables

Conclusion:

The LD50 of the test item is higher than 5000 mg/kg bw by oral route in the rat, in accordance with OECD guideline 423.

According to the criteria of Directive 67/548 EEC and Regulation (EC) No 1272/2008 the test item does not have to be classified.

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