Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed before GLP regulation was established
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DHA,

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 113 (100-120) g
- Housing: Makrolon Typ III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature: 25 +/-2°C
- Humidity: 50-55%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 or 20%
Doses:
800, 1600, 3200, 6400, 12800, 16000 mg/kg body weight
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
The animals were treated by single oral administration (gavage) using a 10 or 20% aqueous DHA solution at the following dose levels: 800, 1600, 3200, 6400, 12500, or 16000 mg/kg bw. The animals were observed for clinical signs and mortality up to 14 days after application. After 14 days all animals were killed and subjected to gross pathological investigation.
Statistics:
No

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was observed during this study.
Clinical signs:
One hour after test item application the animals of the low and mid dose groups showed drowsiness, staggering, and sporadically dyspnoea. The animals receiving 12500 or 16000 mg/kg bw showed dizziness, dyspnoea, twitching and temporary prone position. After 24 hours no clinical signs were observed anymore.
Body weight:
Body weight was unaffected.
Gross pathology:
Gross pathology did not reveal any abnormalities in rats treated with the test item up to 16000 mg/kg bw.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the LD50 of the test item in rats after single oral administration was > 16000 mg/kg body weight.
Executive summary:

The acute toxicity potential of the test item was evaluated following single oral administration to male and female Wistar rats at dose levels of 800, 1600, 3200, 6400, 12500 or 16000 mg/kg bw in water. No deaths were observed in any test item group during the 14-day observation period after administration. One hour after treatment the animals of the low and mid dose groups showed drowsiness, staggering, and sporadically dyspnoea. The animals receiving 12500 or 16000 mg/kg bw showed dizziness, dyspnoea, twitching and temporary prone position. After 24 hours no clinical signs were observed in any test item group. Body weight gain of the treated rats was unaffected. Gross pathology did not reveal any abnormalities in rats treated with the test item up to 16000 mg/kg bw.

Based on the results of this study, the maximum non-lethal dose of the test item in rats after single oral administration is >16000 mg/kg bw. Therefore, the test item is considered to have no toxicity potential after single administration by the oral route.