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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:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to recognised test guideline and sufficiently described for the assessment.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Pent-3-enenitrile
EC Number:
225-060-7
EC Name:
Pent-3-enenitrile
Cas Number:
4635-87-4
Molecular formula:
C5H7N
IUPAC Name:
(3E)-pent-3-enenitrile
Details on test material:
- Name of test material (as cited in study report): Trans-pentene-3 nitrile (T3PN)
- Physical state: clear liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA CREDO
- Age at study initiation: no data
- Weight at study initiation: 147-150 (males), 153-160 (females)
- Fasting period before study: yes (17 h, no water)
- Housing: 5 animals per cage (37.5 x 23.5 x 16 cm)
- Diet: IFFARAT, ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 1°C
- Humidity: 50 +/- 10%
- Air changes: 8 per hr
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous suspension of arabic gum 10%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1 %
- Amount of vehicle: 6 to 12 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: 12 mL/kg
Doses:
0, 60, 80, 100, 120 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
    Behaviour and mortality: at 1, 2, 6 h and daily until day 14
weighing: on days 0, 1, 2, 4, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Method Probit, Litchfield & Wilcoxon, and Arcsinus

Results and discussion

Preliminary study:
5 groups of 4 animals (2 males, 2 females) were given once a dose of 100,  500, 1000, 2500 or 5000 mg/kg. The animals were then observed during 14  days. At 100 mg/kg, 3/4 animals died. At 500 mg/kg or higher, 100% mortality  was observed.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
72 mg/kg bw
Based on:
test mat.
95% CL:
>= 58 - <= 88
Sex:
male
Dose descriptor:
LD50
Effect level:
46.6 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Males are more sensitive than females.
Sex:
female
Dose descriptor:
LD50
Effect level:
93.9 mg/kg bw
Based on:
test mat.
Mortality:
See Table 7.2.1/2
Clinical signs:
Reduced activity, apathy, ptosis at the four doses (60, 80, 100 and 120 mg/kg)
Body weight:
See attached document.
Gross pathology:
Haemoragic digestive tract, thymus and lungs in the animals died during the study
Other findings:
no data

Any other information on results incl. tables

Table 7.2.1/2: Number of animals dead

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths

Male

Female

Combined

 

0

0/5

0/5

0/10

-

60

3/5

0/5

3/10

2 h

80

5/5

1/5

6/10

2 h (M), day 1 (F)

100

5/5

4/5

9/10

2 h (5M+1F), 6 h (1F),1 d (2F)

120

5/5

4/5

9/10

2 h (4M+1F), 6 h (1M), day 1 (3F)

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions and based on the LD50 calculated in males, trans-pentene-3 nitrile is classified in Category 2 (H300) according to the CLP
Regulation 1272/2008/EC and as toxic if swallowed (T; R25) according to the Directive 67/548/EEC.
Executive summary:

In an acute oral toxicity study, groups of fasted Sprague-Dawley rat (5/sex) were given a single oral dose of trans-pentene-3 nitrile (purity unknown) in aqueous suspension of 10% arabic gum at doses of   0, 60, 80, 100 or 120 mg/kg bw and observed for 14 days. At all the tested doses, reduced activity, apathy and ptosis were observed during the study. Haemorrhagic digestive tract, thymus and lungs were noted in the animals died during the study. The oral LD50 are the following:

 

Oral LD50Combined = 72 mg/kg bw (58-88 mg/kg bw)

Oral LD50 males = 46.6 mg/kg bw

Oral LD50 females = 93.9 mg/kg bw

 

At equivalent dose level, mortality was more pronounced in males than in females.

 

Under the test conditions, trans-pentene-3 nitrile is classified in Category 2 (H300, Fatal if swallowed) according to the CLP Regulation 1272/2008/EC and as toxic if swallowed (T; R25) according to the Directive 67/548/EEC.