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Administrative data

Description of key information

Tert-butylperoxyneodecanoatewas tested for acute toxicity by oral, inhalation and dermal routes. The studies revealed an LD50 (oral) value of 8082 mg/kgbw a LC50 value (4 h, inhalation) of greater than 37.5 mg/L and a LD50 (dermal) of greater than 6000 mg/kgbw.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Principles of method if other than guideline:
After some preliminary observations the test material was given undiluted by gavage to groups of five males and five females in single doses. They were observed for signs of intoxication during a 14 days period, after which autopsies were carried out on the survivors.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute`s colony
- Age at study initiation: young adults
- Weight at study initiation: males 243 to 321 g; females 140 to 220 g
- Fasting period before study: overnight
- Housing: in groups of five in screen-bottomed stainless steel cages
- Diet: stock diet ad libitum (after treatment)
- Water: tap water ad libitum (after treatment)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 °C


Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Maximum dose volume applied: 20 mL /kg bw
Doses:
11.6, 13.9, 16.7 or 20.0 mL /kg bw
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
The LD50 was calculated according to the method of Weil (Biometrics 8 (1952) 249-263).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 mL/kg bw
Based on:
test mat.
95% CL:
>= 10.2 - <= 14.4
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 776 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 mg/kg bw
Based on:
act. ingr.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 082 mg/kg bw
Based on:
act. ingr.
Mortality:
Most of the deaths occurred between 21 hours and 8 hours after treatment. One female rat died after 13 days. After 8 days the animals who survived recovered gradually.
Clinical signs:
Within a few hours after treatment all rats showed sluggisness, humpback behavior and severe diarrhoea. Within a few days after treatment several rats showed irritation of the skin in the area arround anus and tailroot; encrustations around eyes and nostrils were frequently observed.
Gross pathology:
At the end of the observation period some of the rats still showed necrosis of the skin around anus and tailroot. No other treatment-related gross alterations were seen at autopsy.

The doses applied and the mortality figures are shown in the table below:

Dose mL/kg

Mortality

Males (number)

Females (number)

%

11.6

3/5

1/5

40

13.9

3/5

3/5

60

16.7

5/5

4/5

90

20.0

5/5

3/5

80

Interpretation of results:
GHS criteria not met
Conclusions:
A LD50 value of 12.0 mL /kg bw (10776 mg/kg bw) for tert-butyl peroxyneodecanoate (75 % solution) was determined in this study and a LD50 value of 9 mL/kg bw (8082 mg/kg bw) was calculated for the pure t-butyl peroxyneodecanoate (actual ingredient). Therefore, the test substance was considered as practically non-toxic.

Executive summary:

Tert-butyl peroxyneodecanoate (75 % solution) was given undiluted by gavage to groups of five males and five females in single doses of 11.6, 13.9, 16.7 or 20.0 mL/kg bw. They were observed for signs of intoxication during a 14 days period, after which autopsies were carried out on the survivors.

The LD50 of the test item was calculated in study to be 12.0 mL/kg bw (10776 mg/kg bw) with 10.2 and 14.4 as the 95 % confidence limits. a LD50 value of 9 mL/kg bw (8082 mg/kg bw) was calculated for the pure t-butyl peroxyneodecanoate (actual ingredient). Therefore, the material was considered practically non-toxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 082 mg/kg bw
Quality of whole database:
Non GLP, but scientifically well documented studies.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
, number of treated animals, no necropsy was made for the survivng animals, additionally test animals and environmental conditions are not indicated
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Charles River CD strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 216 to 266 gr.

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus and exposure chamber volume: each group of rats was placed in a sealed 59.1 L glass chamber and exposed to the appropriate level of test material for 4 hours
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
25, 50, 100, 200 mg/L
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology
Sex:
male
Dose descriptor:
LC50
Effect level:
40.6 mg/L air
Based on:
test mat.
Sex:
female
Dose descriptor:
LC50
Effect level:
64.8 mg/L air
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
50 mg/L air
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
37.5 mg/L air
Based on:
act. ingr.
Remarks on result:
other: Calculated for 100 % of t-butyl peroxyneodecanoate.
Mortality:
At a concentration of 25 mg/L 2 animals out of 10 died
At a concentration of 50 mg/mL 5 animals out of 10 died
At a concentration of 100 mg/mL 8 animals out of 10 died
At a concentrtaion of 200 mg/mL 10 animals out of 10 died
Clinical signs:
other: Eye squint, lacrimation, ocular porphyrin discharge, nasal porphyrin discharge, decreased respiration, dyapnea, salivation, erythema, decreased activity - clinical signs observed during exposure. Cyanosis, eye squint, mydriasis, nasal porphyrin discharge,
Body weight:
Surviving male and female rats at 25.0 mg/L dose level and surviving female rats at 50.0 mg/L dose level exhibited normal body weight gains. Surviving male rats at the 50 mg/L and surviving female rats at dose level of 100 mg/L showed body weight losses during the 14 days observation period.
Gross pathology:
Necropsy findings in rats which died during the exposre/ observation time:
25 mg/L
lung congestion in 1 male and 1 female
hydrothorax, lung edema in 1 female
erosion, hypermia of stomach mucosa in 1 female
50 mg/L
bloody discharge, nose and mouth in 1 female
lung congestion in 2 males and 2 females
lung consolidation, abscesses, hemorrhage in 1 male
lung hemorrhage in 1 male and 1 female
liver congestion in 1 male
100 mg/L
no gross lesions in 3 males
bloody nasal discharge in 1 female
lung congestion in 2 females
lung hemorrhage in 1 male and 1 female
lung edema, hemorrhage in 1 male
200 mg/l
congestion, nasal mucosa, ears in 3 males
congestion nasal mucosa in 2 males
lung congestion, hemorrhage in 5 males and 5 females
dark red liver in 3 males and 2 females
dark red area, spleen in 1 male
Interpretation of results:
GHS criteria not met
Conclusions:
A LC50 value of 50 mg/L was determined in the study for t-butyl peroxyneodecacnoate (75 % in solvent). A LC50 value of 37.5 mg/L was calculated for 100 % t-butyl peroxyneodecacnoate.
Executive summary:

The test substance 75 % t-butyl peroxyneodecacnoate in mineral spirits was examined for its acute inhalation toxicity in a study similar to the OECD no. 403 study guideline. 20 males and 20 female albino rats of the Charles River CD strain were divided equally into 4 dosage group - 25, 50, 100, 200 mg/L. Mortality occurred in all dose groups, 2, 5, 8 and 10 animals out of 10 died at a dose concentration level of 25, 50, 100, 200 mg/L, respectively. Different clinical signs were observed in all dose groups and different necropsy findings were observed in surviving animals of all dose levels. A LC50 value of 50 mg/L was determined in the study for the test substance. A LC50 value of 37.5 mg/L was calculated for 100 % t-butyl peroxyneodecacnoate.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
37 500 mg/m³
Quality of whole database:
Non GLP, but scientifically well documented studies.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
, number of animals per sex and dose, dose levels examined, no necropsy of the survivers
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2374 to 2776 gr.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The hair was clipped from the back of each rabbit. The skin was abraded for 1/2 of the rabbits in each group. The test material was applied, as received, to the backs in appropriate doses. the site of application was covered with gause bandaging and occluded with saran wrap.
Duration of exposure:
24 hours
Doses:
1000, 2000, 4000, 8000 mg/ kg bw
No. of animals per sex per dose:
2 animals of one sex were used for each dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, organ weights
Sex:
male/female
Dose descriptor:
LD0
Effect level:
8 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality was observed
Clinical signs:
Not indicated
Body weight:
All rabbits exhibited body weight gains or maintained their body weight during the14 day observation period
Gross pathology:
Not performed as all animals survived
Interpretation of results:
GHS criteria not met
Conclusions:
A LD50 value of > 8000 mg/kg bw was determined in the study for the test substance 75 % t-butyl peroxyneodecacnoate in solvent. A LD50 value of > 6000 mg/kg bw was calculated for 100 % t-butyl peroxyneodecanoate.
Executive summary:

The test substance 75 % t-butyl peroxyneodecanoate in mineral spirits was examined for its acute dermal toxicity, similar to an OECD no. 402 study guideline. Eight New Zealand white rabbits were equally divided to sex and to 4 dosage groups of 1000, 2000, 4000, and 8000 mg/kg bw. The hair was clipped from the back of each rabbit, the test substance was applied for 24 hours, as received to the backs in appropriate doses and the application site was covered with gauze bandaging and occluded with saran wrap.

After observation time of 14 days no mortality was observed and all rabbits exhibited body weight gains or maintained their body weight during the 14 day observation period. Thus, the deduced LD0 and LD50 values and are 8000 mg/kg bw and > 8000 mg/kg bw respectively. A LD50 value of > 6000 mg/ kg bw is calculated for 100 % t-butyl peroxyneodecanoate.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
6 000 mg/kg bw
Quality of whole database:
Non GLP, but scientifically well documented studies.

Additional information

Acute toxicity oral

Two acute oral toxicty studies were evaluated. In the key study, tert-butyl peroxyneodecanoate (75 % in shellsol) was given undiluted by gavage to groups of five males and five females in single doses of 11.6, 13.9, 16.7 or 20.0 mL/kg bw and were observed for mortality and signs of intoxication during a 14 days period, ended in autopsies which were carried out on the survivors. The LD50 value of the test substance was determined to be 12.0 mL/kg bw (10776 mg/kg bw) and calculated to be 9 mL/kg bw (8082 mg/kg bw) for the pure test substance (acutal ingredient), therefore, the test substance was classified as practically non-toxic.

In the supporting study the test substance 75 % t-butyl peroxyneodecanoate suspended in corn oil was administered in a single oral dose to thirty male rats of the Charles River CD strain in the following dosage (5 rats per dose group): 807.1 , 2034, 3229, 5126, 8137, 12918 mg/kg bw. All surviving rats exhibited normal body weight gains during the study period and no mortality was observed during the study and the 14 days of observation. Thus, the acute oral LD0 and LD50 values in male albino rats was determined to be 12918 mg/kg bw and > 12918 mg/kg bw respectively for the test substance 75 % t-butyl peroxyneodecanoate. A LD50 value of > 9689 mg/kg bw was calculated for the pure t-butyl peroxyneodecanoate (actual ingredient).

Acute toxicity inhalation

The test substance 75 % t-butyl peroxyneodecacnoate in mineral spirits was administered to 20 males and 20 female albino rats of the Charles River CD strain who were divided equally into 4 dosage groups of 25, 50, 100, 200 mg/L. Mortality occurred in all dose groups, 2, 5, 8 and 10 animals out of 10 died at a dose concentration level of 25, 50, 100, 200 mg/L, respectively. Different clinical signs were observed in all dose groups and different necropsy findings were observed in surviving animals of all dose levels. A LC50 value of 50 mg/L and > 50 mg/L respectively was determined for the test substance, 75 % t-butyl peroxyneodecacnoate. A LC50 value of 37.5 mg/L was calculated for 100 % t-butyl peroxyneodecacnoate (actual ingredient).

Acute toxicity dermal

The test substance 75 % t-butyl peroxyneodecanoate in mineral spirits was administered to eight New Zealand white male and female rabbits who were equally divided to 4 dosage groups of 1000, 2000, 4000, and 8000 mg/kg bw. After the hair was clipped from the back of each rabbit, the test substance was applied for 24 hours, as received, to the backs in appropriate doses and the application site in an occlusive bandaging. After observation time of 14 days no mortality was observed and all rabbits exhibited body weight gains or maintained their body weight during the 14 day observation period. Thus, the deduced LD0 and LD50 values were 8000 mg/kg bw and > 8000 mg/kg bw respectively. A LD50 value of > 6000 mg/ kg bw was calculated for 100 % t-butyl peroxyneodecanoate.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data the test item is not classified for acute toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.