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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: the oral LD0 of tert-amyl peroxyoctoate is more than 5000 mg/kg in Sprague Dawley rats (Reagan, 1981)
Acute dermal toxicity: the dermal LD0 of tert-amyl peroxyoctoate is more than 2000 mg/kg in New-Zealand White rabbits (Reagan, 1981)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2a Guideline study without detailed documentations (no certificat of analysis for example)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Sprague Dawley rats, 200-300 g at arrival
- Acllimation periode: 5 days
- Housing: individually
- Fasting overnight
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- All animals were weighted prior to exposure, and at termination.
- Animals were observed daily for 15 days, all gross visible and pharmacological effects were reported.
- No necropsy was performed since no animal died
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
other: All the animals exhibited decreased activity the two or three first days after treatment. Some of them had for one or two days wet, yellow belly
Gross pathology:
Not observed
Interpretation of results:
GHS criteria not met
Conclusions:
The LD0 of tert-amyl peroxyoctotate in rats is more than 5000 mg/kg.
Executive summary:

The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in rats according to a procedure similar to OECD N°401 guideline (Acute Toxic Standard Method) and in compliance with GLP. 10 male and 10 female Sprague Dawley rats were given a single oral dose (5000 mg/kg) of tert-amyl peroxyoctoate. Following treatment, rats were observed daily and weighted at termination. No gross necropsy examination was performed since no mortality occured and since clinical signs (especially decreased activity) were observed only the first days after dosing.

  

Under these experimental conditions, the oral LD0 of tert-butyl peroxyoctoate is more than 5000 mg/kg in Sprague Dawley rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
Klimisch 2 study, GLP compliant.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2a Guideline study without detailed documentations (no certificat of analysis for example)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Acllimation periode: 5 days
- Housing: individually- Food and water ad libidum
- Identification:ear tags and cage cards

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- The back of the animals were clipped free of furw ith electrical clipper on about 30 % of the body surface.
- On the day of the exposure, abrasion of the exposure site was performed for 3 males and 2 females. The abrasions were minor incisions that were not sufficient deep to disturb the derma or induce a bleeding
Duration of exposure:
24 hours, then the exposure site was gently weaped with clean gauze
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations for mortality, clinical signs, local reactions, and toxicological findings were recorded for a total of 14 days.
Body weight were recorded on the inital day of dosing, at day 8, and at study termination
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
other: Diarrhea, digestivetroubles, several days after dosing, for some animals.
Gross pathology:
Not performed
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD0 of tert-butyl peroxyoctoate is more than 2000 mg/kg in New Zealand White rabbits.
Executive summary:

 The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in rats according to a procedure similar to OECD N°402 guideline (Acute Toxic Standard Method) and in compliance with GLP. 5 male and 5 female New Zealand rabbits were given a single dermal dose (2000 mg/kg) of tert-amyl peroxyoctoate. Following treatment, rabbits were observed daily and weighted at termination. No gross necropsy examination was performed since no mortality occured and since few clinical signs were observed (especially digestive troubles).

  

Under these experimental conditions, the oral LD0 of tert-butyl peroxyoctoate is more than 2000 mg/kg in New Zealand White rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Klimisch 2 study, GLP compliant.

Additional information

Acute oral toxicity:

The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in Sprague Dawley rats according to a procedure similar to OECD N°401 guideline (Acute Toxic Standard Method) and in compliance with GLP (Reagan, 1981). The oral LD0 was more than 5000 mg/kg. Clinical signs included decreased activity during the first days following exposure. No gross necropsy examination was performed.

Acute dermal toxicity:

The acute dermal toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in New Zealand White rabbits according to a procedure similar to OECD N°402 guideline (Acute Toxic Standard Method) GLP compliant (Reagan, 1981). The dermal LD0 of tert-butyl peroxyoctoate was more than 2000 mg/kg. The main clinical signs were reported in some animals several days after dosing, and consisted in digestive troubles. No gross necropsy examination was performed.


Justification for selection of acute toxicity – oral endpoint
Key study, Klimisch 2.

Justification for selection of acute toxicity – dermal endpoint
Key study, Klimisch 2.

Justification for classification or non-classification

According to EU directive 67/548/EEC and according to EU Regulation (EC) N0. 1272/2008 (CLP), the substance is not classified for acute toxicity.