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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Conclusion:

Overall the test substance was found to be of low acute toxicity in oral, inhalation and dermal experiments.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP study.
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
Other: acute toxicity, oral, rat
GLP compliance:
not specified
Test type:
other: Acute toxicity: oral
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: unspecified
Vehicle:
other: oil (not specified)
Details on oral exposure:
no data
Doses:
2,5; 5,0; 10,0 ccm/kg bw.
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 other: ccm/kg bw
Remarks on result:
other: corresponds to 9260 mg/kg at a density of 0.926 g/cm³
Mortality:
no mortalities
Clinical signs:
other: diminuated general condition
Gross pathology:
no data
Other findings:
no data

In an acute oral toxicity study the test substance was administered to white male rats.

The animals showed only a diminuated general condition, but no signs of intoxication or mortalities.

The doses tested were: 2.5; 5.0; 10.0 ccm/kg bw. The LD50 was >10.0 ccm/kg bw (corresponds to 9260 mg/kg at a density of 0.926 g/cm³).

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of this substance to the rat was determined to be >9,260 mg/kg bw.
Executive summary:

In an acute oral toxicity study the test substance was administered to white male rats. The animals showed only reduced general condition, but no specific signs of intoxication or mortalities. The doses tested were: 2.5; 5.0; 10.0 ccm/kg bw. The LD50 was >10.0 ccm/kg bw (corresponds to 9260 mg/kg at a density of 0.926 g/cm³)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
>= 9 290 mg/kg bw
Quality of whole database:
The database for acute oral toxicity meets the minimum information requirements under REACH Annex VII, with reliable studies used for the endpoint.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
No OECD guideline or GLP defined, no analytical tests performed.
Principles of method if other than guideline:
other: Acute Toxicity, inhalation in rats
GLP compliance:
no
Test type:
other: Acute Toxicity, inhalation in rats
Species:
rat
Strain:
Wistar
Sex:
not specified
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
other: no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 4 h
Remarks on duration:
Durations from 30 minutes up to 210 minutes were tested.
Concentrations:
298, 287, 283, 452, 457, 447 mg/m³ air
No. of animals per sex per dose:
10
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 447 mg/m³ air
Exp. duration:
4 h

Results:

 Species: rats (mortalities/No Total)  Concentration (mg/m³ air)  Duration (min)  Product (mg min)
 0/10  298  60  17900
 0/10  287  120  34400
 0/10  283  180  51000
 0/10  452  150  67800
 0/10  457  180  82200
 0/10  447  210  93800
Executive summary:

In an old and limited documented acute inhalation toxicity study in Wistar rats, the animals in groups of ten each were given single exposures of test substance aerosol having a mass medium diameter of 1.5µ. The concentrations given were followed: 298 (60min), 287 (120 min), 283 (180 min), 452 (150 min), 457 (180 min), 447 mg/m³ air (210 min). No mortalities were observed and therefore the LC50 was >447 mg/m³ air.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
> 447 mg/m³ air
Physical form:
inhalation: aerosol
Quality of whole database:
The database for acute oral toxicity meets the minimum information requirements under REACH Annex VII, with reliable studies used for the endpoint.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
A valid waiver is used for this study, in accordance with REACH Annex VIII, Section 8.5.3, Column 2.

Additional information

Acute Toxicity: Oral

In an acute oral toxicity study the test substance was administered to white male rats. The animals showed only reduced general condition, but no specific signs of intoxication or mortalities. The doses tested were: 2.5; 5.0; 10.0 ccm/kg bw. The LD50 was >10.0 ccm/kg bw (corresponds to 9260 mg/kg at a density of 0.926 g/cm³) (Kimmerle, Bayer AG, 1958).

In an acute oral toxicity study according to OECD TG 401 and GLP, 5 female and 5 male SD rats were treated once with a dose of 2000 mg/kg bw of test substance. During the course of the study, no deaths occurred in both male and female groups, and no abnormalities that could be attributed to treatment with the test substance were detected in terms of general conditions, change in body weight and pathological examination. The LD50 in male and female rats therefore was >2000 mg/kg bw (CIPC Japan, 1995).

Acute Toxicity: Inhalation

In an old and limited documented acute inhalation toxicity study in Wistar rats, the animals in groups of ten each were given single exposures of test substance aerosol having a mass medium diameter of 1.5 nm. The concentrations given were followed: 298 (60min), 287 (120 min), 283 (180 min), 452 (150 min), 457 (180 min), 447 mg/m³ air (210 min). No mortalities were observed and therefore the LC50 was >447 mg/m³ air (MacFarland, 1966).

In the same laboratory an acute inhalation toxicity study was performed in Hartley guinea pigs, the animals in groups of ten each were given single exposures of test substance aerosol having a mass medium diameter of 1.5 nm. The concentrations given were followed: 450 (30 min), 298 (60 min), 460 (60 min), 287 (120 min), 448 (99 min), 283 mg/m³ air (180 min). The LD 50 was >460 mg/m³ air (MacFarland, 1966).

Acute Toxicity: Dermal

Only limited acute dermal studies are available which are used as supporting information, this endpoint is waived in accordance with REACH Annex VIII, Section 8.5.3, Column 2:

A very limited documented acute dermal toxicity test in female rabbits is available in which different tris(2-ethylhexyl)phosphate test materials (purities not given) were tested at 20 ml/kg bw. Mortality was observed with all 4 samples; 7/10, 5/10, 2/5 and 2/4 respectively (Union Carbide, 1991).

Acute Toxicity: Other Routes

Additionally several other acute studies were performed:

In an acute intravenous toxicity study in New Zealand White rabbits, the animals in groups of six each were given single i.v. injections of the test substance. The following doses were injected: 6.9, 15.4, 36.9, 75.9 and 358.0 mg/kg bw. No deaths occurred in the first four groups; two of the six rabbits received the highest dose died within 24 hours of injection. Therefore the LD50 for i.v. injection was >358.0 mg/kg bw (MacFarland H.N., 1966).

In an acute intra tracheal toxicity study in New Zealand White rabbits, the animals in groups of six each were given single intra tracheal injections of the test substance. The doses given were followed: 36.0, 181.8, 357.3, 690.0, and 1811 mg/kg bw. No deaths occurred at the three lowest doses; the two highest doses caused one death in six rabbits in each case. Therefore the LD50 was >1811 mg/kg bw (MacFarland H.N., 1966). The data from this limited acute intra tracheal study is in agreement with the low acute inhalation toxicity reported by MacFarland et al. (1966).

Justification for classification or non-classification

The substance does not meet the classification criteria for acute toxicity in accordance with Regulation (EC) 1272/2008 (CLP).