Registration Dossier

Administrative data

Description of key information

- Acute toxicity: oral: LD50 > 5000 mg/kg bw (Rel.2, K).
- Acute toxicity: dermal: LD50 > 5000 mg/kg bw (Rel. 2, K).
- Acute toxicity: inhalation: waiver.

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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-guideline and pre-GLP study. Only basic data given. However, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
10 rats were treated with a single dose of 5000 mg/kg bw and observed for a 14-day period
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
none
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
none
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no data
Statistics:
none
Preliminary study:
not applicable
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
one animal died on day 1
Clinical signs:
Rats were slightly lethargic
Body weight:
no data
Gross pathology:
no data
Other findings:
none

none

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 > 5000 mg/kg bw
Executive summary:

In a limit acute oral toxicity study, 10 rats were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days.

 

One animal died on Observation Day 1. No other mortality occurred during the study. Rats were slightly lethargic.

 

Oral LD50 > 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and the Directive 67/548/EEC.

Even if only few details were available on method used in this study, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw which is 2.5 times more than is needed for the OECD 401. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover the acute dermal toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Only basic data given. However, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-guideline and pre-GLP study. Only basic data given. However, the result was non-toxic at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 402. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
A single dermal dose of test material was applied to the skin of 10 rabbits
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
none
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no data
Statistics:
none
Preliminary study:
not applicable
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occurred during the study
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
Skin irritation:
- Slight redness: 5/10
- Moderate redness: 3/10
- Slight edema: 1/10
- Moderate edema: 1/10

none

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

In a limit acute dermal toxicity study, 10 rabbits were exposed to the test material at dose of 5000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions for 14 days.

 

No mortality occurred during the study.

Skin irritation was observed in the animals: 5/10 had slight redness, 3/10 moderate redness, 1/10 slight erythema, 1/10 moderate erythema.

 

Dermal LD50> 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

Even if only few details were available on method used in this study, the result was "non-toxic at 5000 mg/kg bw" which is 2.5 times more than is needed for the OECD 402. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover the acute dermal toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Only basic data given. However, the result was non-toxic at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 402. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.

Additional information

Acute toxicity: oral

A key study was identified (Moreno, 1973, Rel. 2). In this limit acute oral toxicity study, 10 rats were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality for 14 days. One animal died on Observation Day 1. No other mortality occurred during the study. Rats were slightly lethargic.

Oral LD50 > 5000 mg/kg bw.

Acute toxicity: dermal

A key study was identified (Moreno, 1973, Rel. 2). In this limit acute dermal toxicity study, 10 rabbits were exposed to the test material at dose of 5000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions for 14 days. No mortality occurred during the study.

Skin irritation was observed in the animals: 5/10 had slight redness, 3/10 moderate redness, 1/10 slight erythema, 1/10 moderate erythema.

Dermal LD50 > 5000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal routes. Moreover, the vapour pressure of the substance (0.017 Pa at 20°C) indicated an absence of volatility and therefore no exposure by inhalation is anticipated. Thus, at ambient temperature, no respiratory absorption is expected under normal use and handling of the substance.

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the substance is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is greater than 5000 mg/kg bw.

Acute toxicity via Dermal route:

Based on the available information, the substance is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is greater than 5000 mg/kg bw.

Acute toxicity via Inhalation:

This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal):

The classification criteria according to the Annex VI of the Regulation (EC) No 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (dermal) for a Category 1 classification (C ≤ 1000 mg/kg bw) and at the guidance value (dermal) for a Category 2 classification (2000 mg/kg bw ≥ C > 1000 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Inhalation):

This information is not available.