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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984 - 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study woith GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxy-1-naphthaldehyde
EC Number:
211-902-0
EC Name:
2-hydroxy-1-naphthaldehyde
Cas Number:
708-06-5
Molecular formula:
C11H8O2
IUPAC Name:
2-hydroxy-1-naphthaldehyde
Details on test material:
Purity: 94%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Hoe: WISKf (SPF71)
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Weight at study initiation: males: 204+-9.62 g; females: 174,1+-6.62 g
- Fasting period before study: 16 hours
- Housing: in completely air conditioned rooms in macrolon cages in groups of 5 animals
- Diet: Rattendiat Altromin 1324 (ad libitum):
- Water: tap water from plasic bottles (ad libitum):
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hours daily

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
concentration in vehicle: 25% (w/w)
Doses:
see below
No. of animals per sex per dose:
5 females: dose: 4000 mg/kg bw, application volume: 16 ml/kg bw
5 males and 5 females: dose: 5000 mg/kg bw, application volume: 20 ml/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily and weighing: once per week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ observation

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 000 - < 5 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
During the 14-days observation period
after application of 5000 mg/kg bw (5 males and 5 females) one male and four females died
after application of 4000 mg/kg bw ( 5 females) one female died
Clinical signs:
Squatting posture, decreased spontaneous activity, prone position, flanks pinched in, irregular respiration, diarrhoe.
One day after application no more respiration depression but cat bristling pale and yellow skin, dark yellow urine
from day 6 after application all animals were free from clinical sign
Body weight:
No impact on the development of the body weight
Gross pathology:
section of the animals that died during the observation period:
content of stomach and intestine was yellow to orange yellow

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (female rats): 4000 - 5000 mg/kg bw
LD50 (male rats): > 5000 mg/kg bw
Executive summary:

The substance was tested for acute oral toxicity according to OECD guideline 401. 5 male and 5 female Wistar rats were administered a dose of 5000 mg/kg bw and 5 female Wistar rats a dose of 4000 mg/kg bw.During the 14 days observation period after the application one male and four female animals from the 5000 mg/kg bw - group died and one female out of the 4000 mg/kg bw - group.

The LD50 for female rats is therefore between 4000 and 5000 mg/kg bw and for male rats greater than 5000 mg/kg bw.

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