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Administrative data

Description of key information

Acute toxicity: oral: LD50 Combined > 5000 mg/kg bw (similar to OECD 401, rats, K, rel.2);
Acute toxicity dermal: no study available
Acute toxicity inhalation: no study available

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:
December 06, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed prior to the OECD Test Guideline No. 401 but the protocol is similar to that guidance.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: US FHSA CFR 1500.3 (HSLA)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(environmental conditions not reported)
Principles of method if other than guideline:
Acute gavage administration to rats.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, NY.
- Weight at study initiation: 183-225 g
- Fasting period before study: Animals were fasted overnight (ca. 18 h) prior to oral intubation.
- Housing: Animals were housed in wire mesh bottom cages in rooms with temperature control.
- Acclimation period: ca. 2 weeks
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: no data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed three times a day on the day of dosing, twice daily on Day 1 and once daily for the remainder of the study. All gross or visible toxic or pharmacological effects were recorded.
- Necropsy of survivors performed: no; all animals that died during the study were subjected to a complete gross necropsy.
Statistics:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: one of ten animals died on day 2 post dosing
Mortality:
One of ten animals died on day 2 post dosing. The 95 % confidence interval for this 10 % rate of mortality is 0 to 40 % when the test material was administered to rats orally at a level of 5000 mg/kg bw.
Clinical signs:
- Diarrhea was observed in 3/5 females; ataxia in 4/5 male and 5/5 female animals; decreased activity in all animals
Body weight:
- Surviving animals showed expected gains in bodyweight over the 14-day study period.
Gross pathology:
- No abnormalities were noted at necropsy except pale lungs, mottled liver, pale kidneys and small & granular spleen were observed in one male.
Other findings:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 Combined > 5000 mg/kg bw
Executive summary:

In an acute oral toxicity study (limit test) performed similarly to OECD Guideline No. 401 and in compliance with GLP, groups (5/sex/dose) of Sprague-Dawley rats were given a single oral (gavage) dose of test material at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and all the animals that died during the study were sacrificed for macroscopic examination.

One of ten animals died on day 2 post dosing. Diarrhea was observed in 3/5 females; ataxia in 4/5 male and 5/5 female animals; decreased activity in all animals. Surviving animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy except pale lungs, mottled liver, pale kidneys and small & granular spleen were observed in one male.

Oral LD50 Combined > 5000 mg/kg bw.

 

Under the test conditions, the test material is not classified for acute oral toxicity 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:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
The key study is non-GLP compliant but of good 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 available (FDRL 1979, Rel.2). This acute oral toxicity study was performed prior to the OECD test guideline No. 401 but the protocol is similar to that guidance. Groups of rats (5/sex/dose) were administered a single oral (gavage) dose of test material at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and all the animals that died during the study were sacrificed for macroscopic examination.

One of ten animals died on day 2 post dosing. Diarrhea was observed in 3/5 females; ataxia in 4/5 male and 5/5 female animals; decreased activity in all animals. Surviving animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy except pale lungs, mottled liver, pale kidneys and small & granular spleen were observed in one male.

Oral LD50 Combined > 5000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP7.

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 5000 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 significant health effects were observed immediately or delayed after exposure 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.