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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:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: modified 40 CFR 163.81-1
Deviations:
yes
Remarks:
method equivalent to original EU B.1 LD50 method
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Aqueous solution containing ca 70 wt% TBHP
TBHP content 70%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Marland Farms, Hewitt, New Jersey
- Weight at study initiation: 113-163 g
- Fasting period before study: night before study
- Housing: 5 per sex per cage
- Diet (e.g. ad libitum): wayne lab blox
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 days

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Oral gavage assumed
Doses:
0.6, 0.8, 1.0, 1.2, 1.4, 1.6 ml/kg
No. of animals per sex per dose:
10 animals per dose (5 male; 5 female)
Control animals:
no
Details on study design:
Following dosing, the behaviour of the animals were observed frequently for the first day and then four times daily for a period of 14 days. All dead animals were necropsied and survivors were killed with CO2 and necropsied at the end of 15 days.
Statistics:
The LD50 was calculated using the method of Litchfield and Wilcoxon.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 560 mg/kg bw
95% CL:
>= 476 - <= 658
Mortality:
1/10 rats dosed with 0.6 mL/kg, 5/10 rats dosed with 0.8 mL/kg, 7/10 rats dosed with 1.0 mL/kg and 10/10 rats dosed with 1.2, 1.4 and 1.6 mL/kg died during the test period.
Clinical signs:
Depression, pallor, loss of righting, lacrimation, hypothermia and haematuria were observed.
Body weight:
No significant changes to bodyweight
Gross pathology:
Gastric erosions, blood in the GI tract, haematuria. Greyish tan lungs, stomach, duodenums, pancreas and adrenals. Pale kidneys and pancreas were observed at most dose levels.

Any other information on results incl. tables

The LD50 value is reported in terms of both test material (aqueous solution) and TBHP itself (present at 70 wt%): for dry TBHP, an LD50 value of 560 mg/kg was determined.

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Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It is concluded that TBHP in test material is moderately toxic to rats via exposure through the oral route, with an acute LD50 value of 560 mg/kg.
Executive summary:

The study shows that TBHP is moderately toxic to rats when given via the oral route, with an acute LD50 value of 560 mg/kg. The results presented here corresponds to a classification of acute oral toxicity category 4 under Regulation 1272/2008, CLP GHS.