Rosin, maleated

Acute Toxicity: oral

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 for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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 for cross-reference:

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, fumarated, reaction products with formaldehyde

EC Number:

305-795-0

EC Name:

Rosin, fumarated, reaction products with formaldehyde

Cas Number:

95009-65-7

Molecular formula:

C25H35O6

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.