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Administrative data

Description of key information

Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats; GLP, K, Rel.2)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 22 to August 28, 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in compliance with OECD Guideline No. 401 with deviations: purity of the substance is not reported.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Smith, Warlingham, Surrey
- Weight at study initiation: Males: 198-230 g, females: 187-205 g
- Fasting period before study: Animals were fasted overnight before test material administration.
- Housing: Animals were housed in groups of 5/sex in grid bottomed polypropylene cages.
- Diet: Commercially available pelleted rodent diet (Modified 41B supplied by Pilsbury's Limited, Birmingham), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 58-83 %. (humidity of animal room was outside of target ranges but this is considered not to have affected the conditions of this study)
- Photoperiod: 12 h dark/ 12 h light

Route of administration:
oral: gavage
Vehicle:
other: 0.25 % aqueous solution of gum tragacanth
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

DOSAGE PREPARATION (if unusual): Test material was suspended in a 0.25 % aqueous solution of gum tragacanth.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 rats/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined for signs of toxicity or other effects frequently after dosing and then daily for 14 days. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: Yes; on completion of the observation period, all surviving animals were sacrificed by carbon dioxide asphyxiation and subjected to gross necropsy. Animals which died during the course of the study were also subjected to gross necropsy.
Statistics:
None
Preliminary study:
Not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 2/5 male and 2/5 female animals were died within 4 h of dosing.
Mortality:
- 2/5 male and 2/5 female animals were died within 4 h of dosing.
Clinical signs:
- No clinical signs were observed.
Body weight:
- All animals showed expected gains in bodyweight over the 14 day study period.
Gross pathology:
- No abnormalities were noted at necropsy.
Other findings:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 Combined > 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 401 and in compliance with GLP, a group of Sprague Dawley rats (5/sex) were administered a single oral dose of test material at 2000 mg/kg bw by gavage. Animals were observed for mortality, and clinical signs after dosing and then daily for 14 days. Individual bodyweights were recorded on Day 1, 8 and 15 and then necropsied for macroscopic observations.

2/5 male and 2/5 female animals were died within 4 h of dosing. No clinical signs were observed. All animals showed expected gains in bodyweight during the study. No signs of gross pathological change were found by necropsy.

Oral LD50 Combined > 2000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The key study is GLP-compliant and of high quality (Klimisch score = 2)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: oral

A key study was identified (Toxicol, 1986). In this acute oral toxicity study, performed according to OECD Guideline No. 401 and in compliance with GLP, a group of Sprague Dawley rats (5/sex) were administered a single oral dose of test material at 2000 mg/kg bw by gavage. Animals were observed for mortality, and clinical signs after dosing and then daily for 14 days. Individual bodyweights were recorded on Day 1, 8 and 15 and then necropsied for macroscopic observations.

2/5 male and 2/5 female animals were died within 4 h of dosing. No clinical signs were observed. All animals showed expected gains in bodyweight during the study. No signs of gross pathological change were found by necropsy.

Oral LD50 Combined > 2000 mg/kg bw.

This result is confirmed by a supporting study (Battelle, 1969), pre-GLP and pre-OECD, which give an Oral LD50 Combined = 2920 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
The most reliable study was selected as the key study for this endpoint.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP6.

Self-classification:

Acute toxicity via Oral route:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw.

Acute toxicity via Dermal route:

No data was available.

Acute toxicity (Inhalation):

No data was available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal):

No data was available.

Specific target organ toxicity: single exposure (Inhalation):

No data was available.