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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lucirin LR 8728 [Chemical name: diphenyl (2,4,6-trimethylbenzoyl) phosphineoxide]
- Analytical purity: not reported
- Physical state: pale yellow-coloured powder
- Lot/batch No.: 010213
- Storage condition of test material: stored in brown glass screw-top jars at approximately 4°C in the refrigerator

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CFY strain rats supplied by Bantin & Kingman Ltd, Grimston, Aldborough, Hull, UK
- Age at study initiation: approximately five to eight weeks old
- Weight at study initiation: mean weights: males weighed 126 - 150g, and the females 120 - 142g,
- Fasting period before study: overnight immediately before dosing and for approximately two hours after dosing
- Housing: 5 by sex in solid-floor polypropylene cages with sawdust bedding; the animals were given a unique number within the study by ear punching and a number written on a cage card
- Diet: Rat and Mouse Expanded Diet No 1, Special Diet Services Ltd, Witham, Essex, UK; ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 46 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50, 100, 300 and 500 mg/ml
- Amount of vehicle (if gavage): 10 ml
- Justification for choice of vehicle: test substance administered as suspension
Doses:
5000 mg/kg bw
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: animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
- Other examinations performed: individual body weights were recorded on the day of treatment (day 0) and on days 7 and 14

Results and discussion

Preliminary study:
Because no deaths occurred in the range-finding study, LD50 of the test substance was considered to be greater than 5000 mg/kg bw and the highest dose level was therefore used for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no mortality occured
Mortality:
no mortality
Clinical signs:
- Hunched posture, lethargy and piloerection were noted in all animals one and four hours after dosing.
- Decreased respiratory rate was also noted in all animals one hour after dosing.
- All animals appeared normal one day after treatment.
Body weight:
all animals showed expected gain in body weight over the study period (see table).
Gross pathology:
no abnormalities were noted at necropsy of animals (killed at the end of the study).

Any other information on results incl. tables

Mean body weights (g):

Males:

Time  5000 mg/kg bw group
 Day 0  137.6±9.6
 Day 7  170.8±11.6
 Day 14  216.2±12.5

Females:

Time  5000 mg/kg bw group
 Day 0  128.8±8.4
 Day 7  152.6±7.7
 Day 14  180.6±12.0

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information