Registration Dossier

Administrative data

Description of key information

Acute oral and dermal toxicity data on the registered substance, DOWFAX 2A1, indicate that GHS criteria for classificaiton are not met.

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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP, but the report contains sufficient data for interpretation of study results.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Observations and body weights were recorded over a 2-week period following dosing.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Fischer 344
Sex:
female
Details on test animals and environmental conditions:
No data
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
2000 mg/kg of the neat test material by single-dose oral gavage
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Observations and body weights were recorded over a 2-week period following dosing.
Statistics:
None
Preliminary study:
None
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
Clinical signs indicative of systemic toxicity in the 2000 mg/ kg dose level consisted of fecal and urine soiling, salivation, chromorhinorrhea, decreased activity, and thin appearance. The clinical signs were first observed two hours post dose and persisted through test day four.
Body weight:
While one of the rats initially lost weight, all animals gained weight over the two week observation period.
Gross pathology:
None
Other findings:
No data

None

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
The estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg.
Executive summary:

A sample of Dowfax 2A1 was submitted by Specialty Chemicals, The Dow Chemical Company, Midland, MI for evaluation of acute oral and dermal toxicity and skin and eye irritation.

In the acute oral toxicity test, three female Fischer 344 rats received 2000 mg/kg of the neat test material by single-dose oral gavage. Clinical signs indicative of systemic toxicity in the 2000 mg/kg dose level consisted of fecal and urine soiling, salivation, chromorhinorrhea, decreased activity, and thin appearance. The clinical signs were first observed two hours post dose and persisted through test day four. While one of these rats initially lost weight, all animals gained weight over the two-week observation period. The estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
acceptable

Acute toxicity: via inhalation route

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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP, but the report contains sufficient data for interpretation of study results.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Following exposure, observations and body weights were recorded over a 2-week period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
No additional data
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 male rabbits/dose
Control animals:
no
Details on study design:
In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat Dowfax 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Following exposure, observations and body weights were recorded over a 2-week period.
Statistics:
None
Preliminary study:
Not applicable
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a slightly abraded site (minor incision through the stratum corneum of insufficient depth to produce bleeding), caused only very slight imtation to the skin, it is felt that these burns may be a result of the procedure used in preparing the animals for testing. These observations were noted through test day four in one animal, and test day eight in the other. By test day eight, both animals were observed with scaling, which persisted through the end of the study.
Body weight:
Administration of DOWFAX 2A1 at 2000 mg/kg had no apparent effect on body weight during the two week observation period.
Gross pathology:
No data
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.
Executive summary:

A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a slightly abraded site (minor incision through the stratum corneum of insuffiaent depth to produce bleeding), caused only very slight irritation to the skin, it is felt that these burns may be a result of the procedure used in preparing the animals for testing. These observations were noted through test day four in one animal, and test day eight in the other. By test day eight, both animals were observed with scaling which persisted through the end of the study. Administration of DOWFAX 2A1 at 2000 mg/kg had no apparent effect on body weight during the two-week observation period. The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
acceptable

Additional information

In the studies conducted with DOWFAX 2A1, the acute oral and dermal toxicity were low, with LD50 values in excess of 2000 mg/kg bw, and no deaths were observed. This is also true for the other ADPODS substances relevant for read across, indicating that this particular group of chemicals has a low order of toxicity via the oral and dermal routes (refer to full ADPODS category justification document).

No data are available for inhalation toxicity. However, this is unlikely to be a relevant route for human exposure due to the low vapour pressure and limited possibility for generating a large concentration of aerosol in normal handling conditions.


Justification for selection of acute toxicity – oral endpoint
acceptable limit dose study for the REACH registered substance

Justification for selection of acute toxicity – dermal endpoint
acceptable limit dose study for the REACH registered substance

Justification for classification or non-classification

No classification is required for acute toxicity based on the study outcomes.