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Description of key information

For all the endpoints of the chapter 7.2, the name of the tested substance is DV-SOLV 1059.
The DV-SOLV 1059 is the previous name of the Rhodiasolv Polarclean. The specifications of the DV-SOLV 1059 are in line with the dossier and representative of the industrial product manufactured by Schirm.
An acute oral and an acute dermal toxicity studies were performed in rat. The LD50 were > 2000 mg/kg bw in both studies .

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:
From 7 August 2009 to 15 October 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. Toxi Coop Ltd., Budapest
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 218-234 g
- Fasting period before study: overnight until 3 hours after treatment
- Housing: Group caging, 3 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 27 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11 August 2009 To: 26 August 2009
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3+3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing then daily for 14 days.
Bodyweight on Day -1, Day 0, Day 7, Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
None
Body weight:
No effect
Gross pathology:
No abnormal findings

The median lethal dose of DV-SOLV 1059 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DV-SOLV 1059 is not classified as hazardous by ingestion according to the criteria of EU DSD or EU GHS
Executive summary:

Two groups, each of three femaleCRL: (W1) BR Wistar rats, were treated with DV-SOLV 1059 by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was administered undiluted at a dosing volume of 1.92 mL/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs and mortality within the first 30 minutes and approximately 1, 2, 3, 4 and 6 hours after treatment on day 1 and once daily during test days 2-15. Body weights were recorded on Day -1, Day 0 (prior to administration) and on days 7 and 14. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of DV-SOLV 1059 after single oral administration to female rats, observed over a period of 14 days is: LD50(female rat): greater than 2000 mg/kg body weight.

Based on the results of this study, the test substance DV-SOLV 1059 is not classified according to the criteria of Annex VI of Directive 67/548/EECand EU GHS.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP-compliant study performed according to the OECD 423 Guideline (Klimisch score = 1)

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:
from 6 January 2011 to 6 April 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Wistar (RccHan:WIST)
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 231-342 g(m) 202-217 (f)
- Fasting period before study: not applicable
- Housing: groups of 5 by sex (individually during exposure)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: from 16 February 2011 to 2 March 2011
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Red/brown staining around the snout was noted in two males during the day of dosing.
Body weight:
No effect
Gross pathology:
No effects
Other findings:
None
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Rhodiasolv Polarclean does not require labelling as hazardous for the skin according to the criteria of Regulation 1272/2008 or UN GHS.
Executive summary:

A study was performed to assess the acute dermal toxicity of Rhodiasolv Polarclean in the Wistar strain rat. A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. Red/brown staining around the snout was noted in two males during the day of dosing. There were no other signs of systemic toxicity noted. There were no signs of dermal irritation. Animals showed expected gains in bodyweight over the study period except for one female which showed bodyweight loss during the first week but expected gain in bodyweight during the second week. No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP-compliant study performed according to the OECD 402 Guideline (Klimisch score = 1)

Additional information

Oral:

On study of reliability 1 according to Klimisch cotation critera, is available for oral route (Nagy K., 2009) and was selected as a key study. In this study, 3 Wistar female rats were given a single oral dose of undiluted DV-SOLV 1059 at the dose of 2000 mg/kg bw and observed for 14days. No mortality or clinical signs was observed. There was no effect on body weight gain.No macroscopic findings were recorded at necropsy.

Based on this study, the LD50 for oral route in rats was higher than 2000 mg/kg bw. No classification for acute oral toxicity is therefore warranted on the basis on these in vivo data.

Inhalation:

In accordance with column 2 of REACH Annex VIII, an acute inhalation toxicity study does not need to be conducted as exposure of humans to the substance is unlikely, taking into account its very low vapour pressure (<0.01Pa at20°C).

Dermal:

On study of reliability 1 according to Klimisch cotation critera, is available for dermal route (Pooles L., 2011) and was selected as a key study. In this study, 5 male and 5 female Wistar rats were dermally exposed to undiluted DV-SOLV 1059 for 24 hours to 10% of body surface area at the dose of 2000 mg/kg bw.  Animals were then observed for 14days. No mortality was noted during the study.Red/brown staining around the snout was noted in two males during the day of dosing. There were no other signs of systemic toxicity noted. There were no signs of dermal irritation. Animals showed expected gains in bodyweight over the study period except for one female which showed bodyweight loss during the first week but expected gain in bodyweight during the second week.No abnormalities were noted at necropsy.

Based on this study, the LD50 for dermal route in rats was higher than 2000 mg/kg bw. No classification for acute oral toxicity is therefore warranted on the basis on these in vivo data.


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

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

Justification for classification or non-classification

In the absence of mortality following exposure of rats to limit test doses or concentrations and a 2-week observation period whatever the route of administration, no classification for acute toxicity is warranted according to the criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP).