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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
yes
Remarks:
Std 12:12 light/dark cycle of the room housing animals 1, 2, 3, 4, and 5 briefly disrupted. Limit test completed using 5 animals rather than 6; a sufficient number had survived and decision was made to not use additional replacement animal.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Rosin, reaction products with acrylic acid
EC Number:
280-192-2
EC Name:
Rosin, reaction products with acrylic acid
Cas Number:
83137-13-7
Molecular formula:
N.A. - UVCB substance
IUPAC Name:
Rosin, reaction products with acrylic acid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 646729
- Expiration date of the lot/batch: 19 November 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and humidity

FORM AS APPLIED IN THE TEST (if different from that of starting material): The test article was ground with a mortar and pestle. 2.0 g of ground test article were mixed with PEG 400 to a total volume of 10 ml.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Raleigh NC and Stone Ridge NY
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weks
- Weight at study initiation: Mean 197 g (187-213 g)
- Fasting period before study: 16-20 hours prior to test article administration
- Housing: Animals will be housed in suspended wire cages which conform to the size recommendations in Guide for the Care and Use of Laboratory Animals DHEW (NIH). Rats will be housed 5 per sex per cage prior to dosing and 3 per sex per cage following dosing. Absorbent paper bedding, placed beneath the cage, will be changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet #5012) will be available except 16 - 20 hours prior to dosing.
- Water (e.g. ad libitum): Water will be available ad libitum.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hour light:dark

IN-LIFE DATES: From: 18 July 2017 To: 09 August 2017

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg (in 10 mL/kg vehicle)
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Based on protocol OECD 423 (2001).
- Lot/batch no. (if required): Lot/Batch 156715

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose level to be used as the starting dose level was selected from one of four fixed levels. The starting dose level should be that which is most likely to produce mortality in some of the dosed animals.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 15 minutes (+/- 5 minutes), 1, 2 and 4 hours postdose; daily thereafter for 14 consecutive days for toxicity and pharmacological effects and twice daily for mortality. Body weights were recorded immediately pretest, weekly and at death or study termination in the survivors.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
During dose administration, an indeterminate amount of the test article was aspirated by animal 6. Because the animal did not receive the intended dose volume, the animal was euthanized and no gross necropsy was performed.
Clinical signs:
other: No abnormal clinical signs were observed.
Gross pathology:
The gross necropsy revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, the rat oral LD50 of the test article is >2000 mg/kg bw.
Executive summary:

The acute oral lethality of the test article was determined in female Sprague-Dawley rats. The study was performed in compliance with OECD GLP (1997). The test method was based on OECD 423 (2001). The test article was dissolved in PEG 400 to achieve the appropriate dose. Initially, fasted female rats (n = 3) received a single 2000 mg/kg bw oral dose of the test article via oral gavage at a volume of 10 mL/kg. As all animals survived that dosing, another group of 3 female rats were dosed in a similar manner as a confirmatory group. Observations for mortality were made twice daily for mortality and body weights were recorded immediately pretest weekly, and at death or study termination in the survivors. Observations for clinical signs of toxicity were made at 15 minutes (+/- 5 minutes), 1, 2, and 4 hours post dose and daily thereafter for 14 consecutive days. Necropsy was performed on all surviving animals at termination. During dose administration, an indeterminate amount of the test article was aspirated by one confirmatory animal. Because the animal did not receive the intended dose volume, the animal was euthanized and no gross necropsy was performed. The remaining five animals survived and no abnormal physical signs were observed. All five animals gained body weight by study termination. No gross abnormalities were observed at necropsy. Based on the results of the study, the rat oral LD50 of the test article is >2000 mg/kg bw.