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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Internal BASF method was used which was in large part equivalent to OECD guideline 401
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Valeraldehyde
EC Number:
203-784-4
EC Name:
Valeraldehyde
Cas Number:
110-62-3
Molecular formula:
C5H10O
IUPAC Name:
valeraldehyde
Details on test material:
- Name of test material (as cited in study report): n-Valeraldehyd
- Physical state: fluid
- Substance No.: XXVI 30

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: mean 170 g (male), 150 g (female)
- Diet (e.g. ad libitum): ad libitum, Altronin R 1121
- Water (e.g. ad libitum): tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% CMC with Cremophor EL
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 46.4, 50%
- Amount of vehicle (if gavage): 20 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 3.4 ml
Doses:
4640, 6810, 10000 ul/kg bw (approx. 3763, 5522, 8109 mg/kg bw based on a density of 0.8109 g/ml)
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 and weighing: daily observations and weighing prior to study and days 2, 7 and 13
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 6 490 mg/kg bw
Remarks on result:
other: LD 50 converted from the orignally reported value of 8 mL/kg bw (based on a density of 0.8109 g/ml)
Mortality:
4640 µl/kg bw (3763 mg/kg bw): no mortality
6810 µl/kg bw (5522 mg/kg bw): 2/5 males within 24 h; 1/5 females within 24 h
10000 µl/kg bw (8109 mg/kg bw): 4/5 males within 24 h; 4/5 females within 24 h
Clinical signs:
dyspnoea, apathy, face-down, lateral and dorsal position, staggering, atony, narcosis-like state with loss of pain- and corneal reflex, spastic move, exsiccosis, exophtalmus, reduced general state
Body weight:
listed in table below
Gross pathology:
heart: akut bilateral dilatation, congestive hyperemia
stomach: gastroesophageal vestibule septum thickened and sclerotic, agglutination, cauterisation gastritis

Any other information on results incl. tables

Mean weights:

dose (µl/kg bw) sex mean weight (g)
prior to study d 2 d 7 d 13
10000 m 170 176 194 223
f 150 156 176 188
6810 m 170 181 252 252
f 150 152 190 190
4640 m 170 194 225 242
f 150 171 183 194

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of valeraldehyde was determined to be 6490 mg/kg bw. No classification is required according to EU legislation.
Executive summary:

The acute oral toxicity of valeraldehyde was determined in groups of 5 male and 5 female Sprague-Dawley rats receiving the test material by oral gavage at doses of 3760, 5520, 8110 mg/kg bw. The observation period was 14 days. The LD50 was estimated using a graphical evaluation of the dose response curve on probability paper. Overall, the study was conducted in accordance with the recently retracted OECD test guideline 401.

 

The acute oral LD50 was determined to be 6490 mg/kg bw in rats (BASF, 1977).