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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because the study appears to adhere to the principles outlined in OECD 420 and was GLP compliant.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
This study was assessed using OECD 420 rather than 401 since OECD 401 is no longer supported by OECD.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Neodene 6
- Substance type: C6 alpha olefin
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Neodene 6
- Substance type: C6 alpha olefin
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries, Indianapolis, Indiana
- Weight at study initiation: Weights recorded on day 0
- Fasting period before study: Yes
- Housing: Individually caged
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0 to 25.0
- Humidity (%): 36 to 71%
- Photoperiod (hrs dark / hrs light): 12 dark/12 light

IN-LIFE DATES: From: 1981-06-30 To: 1981-07-30

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Specific amount of test material administered calculated using fasted body weights on day 0 and specific gravity of 0.673 for Neodene 6.
Doses:
0, 1000, 1800, 3200, and 5600 mg/kg Neodene 6, 10 ml/kg deionised water (control)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: Observations for clinical signs of toxicity were made hourly for six-hours post-dosing, at 24 hours and twice daily until study termination on day 14. Body weights were determined on days -1, 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs, body weight
Statistics:
Statistical analysis of body weights included calculation of the mean and standard error. Determination of the significance of body weight changes on days 7 and 14 compared to controls was made using an independent T-test. A probability level of 0.05 was used as criterion for significance. No information reported on method used to calculate LD50.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 600 mg/kg bw
Mortality:
No deaths were reported in this study.
Clinical signs:
Mucoid diarrhoea was observed over the first day in treated rats. Other clinical effects observed included polyuria, hyperactivity, hypoactivity, chewing movements, hypersensitivity to touch, red eye discharge, soft stool, and diarrhea. Many of the effects were inconsistent, of low incidence, and poorly dose related. Control rats were observed to have diarrhoea, soft stool, hyperactivity, and hypersensitivity to sound/touch.
Body weight:
No effects on body weight were reported.
Gross pathology:
The only remarkable change observed during necropsy was bilateral luminal dilation with clear fluid in the uterus which did not occur in the controls, but occurred in 4/5 of 1000 mg/kg treated females, 1/5 of 3200 mg/kg treated females, and 4/5 of 5600 mg/kg treated females. The pathologist noted that this was a common occurrence and it was not considered treatment-related.
Other findings:
One female rat treated with 1800 mg/kg Neodene 6 had dyspnoea on days 11 to 14 and a red nasal discharge on day 13. A partial occlusion of the trachea and bronchi was found at necropsy. These findings were not considered treatment-related.

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for Neodene 6 was reported to be > 5600 mg/kg in the rat.
Executive summary:

In an acute oral toxicity study, groups of fasted Fisher 344 rats (5 male, 5 female) were given a single oral dose via gavage of Neodene 6 at doses of 0, 1000, 1800, 3200, or 5600 g/kg bw and observed for 14 days. Controls received deionised water. 

No deaths occurred during this study and body weight was not affected by treatment. Clinical signs of toxicity included mucoid diarrhoea over the first day in treated rats. Although there were other clinical signs noted, they also occurred in the controls and were sporadic and therefore not related to treatment. The only remarkable change observed during necropsy was bilateral luminal dilation with clear fluid in the uterus of some treated females rats. This change, which was not observed in control animals, occurred in 4/5 of 1000 mg/kg treated females, 1/5 of 3200 mg/kg treated females, and 4/5 of 5600 mg/kg treated females. The pathologist noted that this was a common occurrence and it was not considered treatment-related. The acute oral LD50 for Neodene 6 alpha olefin in male and female rats was reported as >5600 mg/kg.

This study received a Klimisch score of 1 and is classified as reliable with restriction because it was conducted in accordance with OECD 420 and was GLP compliant.