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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 July 1980 to 6 August 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Used for read across to Pinyl Isobutyraldehyde
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information is derived from read across
Justification for type of information:
The read across justification is presented in the acute toxicity endpoint summary and the accompanying files are also attached there.
Reason / purpose:
read-across source
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not acute toxic
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
Based on the results of the study for read-across substance Floralozone, Pinyl Isobutyraldehyde (PIBA) is considered to be not acute toxic via the oral route.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Details on test material:
As described in 1.2 of dossier

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: 8 weeks
- Weight at study initiation: 221 – 250 g
- Fasting period before study: 16 – 20 hours
- Housing: animals were housed 5 per cage in suspended wire mesh cages
- Diet: fresh Purina rat chow, ad libitum
- Water: ad libitum
- Acclimation period: at least one week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed 3-4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Cas no of Floralozone is 67634-15-5
Mortality:
4 out of 10 animals exposed to 5000 mg/kg bw died.
Clinical signs:
Lethargy was noted in 5 animals on day 1. Oily anogenital area was noted in 5 or more animals on day 1 and 2. The survivors were normal until day 11 and 12 when piloerection was noted in several animals. Ptosis was noted in 1 animal on day 13. The surviving animals were normal on day 14.
Gross pathology:
- No effects were observed in the animals that were sacrificed on day 14.
- Stained brown anogenital area, congested lung, dilated heart, excess fluid in pleural cavity, stomach and intestines distended, intestines grey and/or purple and pale exudate contained in pleural cavities and pericardium were observed in animals that died.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute toxic
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.
Executive summary:

Floralozone is tested for acute oral toxicity in a study performed similar to OECD TG 401. Ten male Wistar rats were exposed to the test substance via oral gavage. Animals received a dose of 5000 mg/kg bw. After an observation period of 14 days animals were necropsied. In this study 2 animals died at day 2, one at day 6 and one at day 12. Lethargy and oily anogenital area was noted in 5 or more animals. The survivors were normal until day 11 and 12 when piloerection was noted in several animals. Ptosis was noted in 1 animal on day 13. The surviving animals were normal on day 14. No effects were observed upon necropsy in the animals that were sacrificed on day 14. In the animals that died the following effects were seen: stained brown anogenital area, congested lung, dilated heart, excess fluid in pleural cavity, stomach and intestines distended, intestines grey and/or purple and pale exudate contained in pleural cavities and pericardium.The LD50 was determined to be higher than 5000 mg/kg bw.