Resin acids and Rosin acids, barium salts

Endpoint summary

Description of key information

Since no experimental data regarding the acute toxicity of the test substance were available, a weight of evidence approach for the endpoint acute oral toxicity was conducted to determine hazard classification. It was concluded that the test substance is harmful by inhalation and if swallowed according to the harmonised classification and labelling for barium salts approved by the European Union (Regulation (EC) 1272/2008 Annex VI; Index-no: 056-002-00-7 / CLP 00).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Acute oral toxicity

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

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:

Young female adult animals (approx. 14- 18 weeks) with a comparable weight were used.
Acclimatization for at least 5 days.
Individual animal identification by cage cards and tail marking.
One animal per cage (type: stainless steel wire mesh cages, type DK-lll).
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity.
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum. Feed was withdrawn from the animais at least 16 hours before administration, but water was available ad libitum.

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Olive oil Ph.Eur/DAB had to be used to ensure homogeneity of the preparation.
The test substance preparation was produced for each administration group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax ) and a magnetic stirrer.
Form of administration: suspension
Concentration used: 40 g/100 ml
Application volume: 5 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

Observation period: at least 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Necropsy with gross-pathological examination on the last day of the observation period after killing with CO2.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: No clinical observations were observed during clinical examination.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (6 females) examined at termination of the study.

RS-Freetext:
- No mortality occurred.
- No clinical signs and findings were observed.
- The mean body weights of the administration groups
  increased throughout the study period.
- No macroscopic pathologic abnormalities were noted in the
  animals examined at the end of the observation period.
- The median lethal dose of BREMAZIT 5060 after oral
  administration was found to be greater than 2,000 mg/kg
  body weight in rats.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: formulation tested. Limit dose for test substance not reached (only 1200 mg/kg bw tested), non GLP, similar to guideline

Justification for type of information:

ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Acute oral toxicity

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

calculated on content of CAS 9008-34-8, dose only 1200 mg/kg bw; higher number of animals, 8 instead of 14 days post-observation.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

content of rosin and resin acids, manganese salts = 12%
other component: poorly soluble manganese complex
Physical state: red solid

Species:

rat

Strain:

other: CFE

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy young random bred rats of the CFE (RAC, SPF) strain purchased from the breeder were used for these experiments. The mean initial body weight was between 129 and 151 g. Before starting, the animals were acclimatized for at least 5 days in our laboratories to a constant room temperature of 22°C, relative humidity of 55 % and 14 hours light/day. They were housed in groups of 5 in macrolon cages (size 3). A standard diet of Nafag and
drinking water were given "ad libitum".

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Rats received by gavage various doses (see table 1 ) of a preparation suspended with 0.5% carboxymethyIcellulose and tap water.
The total volume given was 20 ml/kg body weight.

Doses:

5000 and 10000 mg/kg bw (corresponds to 600 and 1200 mg/kg bw of CAS 9008-34-8)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Symptoms and mortality after administration were recorded during an observation period of 8 days.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 1 200 mg/kg bw

Based on:

other: content of CAS 9008-34-8

Remarks on result:

other: No mortality occurred.

Clinical signs:

other: at 10000 mg/kg bw: sedation

Other findings:

red stained feces at both doses
red stained urine at 10000 mg/kg bw
The red coloration is caused by the intrinsic color of the main component of the formulation and is not an adverse effect.

Interpretation of results:

other: Considering the absence of adverse effects at 1200 mg/kg bw, the LD50 is unlikely to be greater than 2000 mg/kg bw.

Conclusions:

Considering the absence of adverse effects at 1200 mg/kg bw, the LD50 is unlikely to be greater than 2000 mg/kg bw.

Executive summary:

In a supporting acute oral toxicity study, the test material (CAS# 9008-34-8; 12% formulation) was administered to young adult CFE rats (5/sex/dose) via oral gavage at doses of 5000 and 10000 mg/Kg bw (corresponding to 600 and 1200 mg/Kg of the test material) in a carboxymethyl cellulose vehicle. No mortality was observed at the highest dose tested.

Considering the absence of adverse effects at 1200 mg/kg bw, the LD₅₀ was determined to be ≥1200 mg/Kg bw.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

other: Publication

Adequacy of study:

weight of evidence

Study period:

no data available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Acute oral toxicity

Qualifier:

no guideline available

Principles of method if other than guideline:

No further information on the test principles, but the LD50 for acute oral toxicity in rats is given.

GLP compliance:

not specified

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Control animals:

not specified

Statistics:

No data available.

Sex:

not specified

Dose descriptor:

LD50

Effect level:

118 mg/kg bw

Based on:

not specified

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The test substance is legally classified as toxic via ingestion according to Regulation (EC) 1272/2008 Annex VI; Index-no: 056-004-00-8 / CLP00, as amended for the fourteenth time in Regulation (EU) No. 2020/217.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - see justification attached to IUCLID section 7.2.1 Acute toxicity: oral

- Justification for WoE: Acute oral toxicity

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. For acute oral toxicity no experimental data of the test substance itself are available. According to the harmonised classification and labelling for barium salts approved by the European Union (Regulation (EC) 1272/2008 Annex VI; Index-no: 056-002-00-7 / CLP 00) and available acute oral toxicity data from read-across, classification with Cat. 4 for acute toxic effects (harmful by inhalation and if swallowed) is warranted according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EU) No. 2020/217.