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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose:
read-across source
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

No mortality, no clinical signs, body weight gain normal, no treatment related changes on macroscopic examination.

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Rosin, fumarated, reaction products with formaldehyde is greater than 2000 mg/kg bw by the oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item of Rosin, fumarated, reaction products with formaldehyde cannot be classified because it cannot be determined whether the LC50 falls in Category IV (< 2000 mg/kg) or outside of the category.

In accordance with the Globally Harmonised System (Regulation (EC) No. 1272/2008) the test item cannot be classified because it cannot be determined whether the LC50 falls in Category V (< 5000 mg/kg) or outside of the category.
Executive summary:

This data is being read across from the source study that tested Rosin, fumarated, reaction products with formaldehyde based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

In an acute oral toxicity study, a single dose of rosin, fumarated, reaction products with formaldehyde was administered via gavage to six female rats were at a concentration of 2000 mg/kg. No mortality occurred and there were no treatment-related signs of toxicity. The acute oral LD50 in this study was >2000 mg/kg bw for female rats. 

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
rosin, fumarated, reaction products with formaldehyde, CAS no 95009-65-7- Name of test material (as cited in study report):
- Substance type: chemically modified UVCB
- Physical state: Brown solid
- Analytical purity: 100%
- Lot/batch No.: 151009
- Expiration date of the lot/batch: not stated

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No mortality, no clinical signs, body weight gain normal, no treatment related changes on macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Rosin, fumarated, reaction products with formaldehyde is greater than 2000 mg/kg bw by the oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item of Rosin, fumarated, reaction products with formaldehyde cannot be classified because it cannot be determined whether the LC50 falls in Category IV (< 2000 mg/kg) or outside of the category.

In accordance with the Globally Harmonised System (Regulation (EC) No. 1272/2008) the test item cannot be classified because it cannot be determined whether the LC50 falls in Category V (< 5000 mg/kg) or outside of the category.
Executive summary:

In an acute oral toxicity study, a single dose of rosin, fumarated, reaction products with formaldehyde was administered via gavage to sixfemale rats were at a concentration of 2000 mg/kg. No mortality occurred and there were no treatment-related signs of toxicity. The acute oral LD50 in this study was >2000 mg/kg bw for female rats.