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Endpoint summary

Description of key information

The acute toxicity of MDP was evaluated in female sprague dawley rats. The results were:

When tested according to OECD 423: Rat Oral LD50 > 2,000 mg/kg body weight.

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:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

Remarks:

No deviations ocurred that impacted the integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot FiS 18/013
- Purity, including information on contaminants, isomers, etc.: Reaction mass ass described in the general information section.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING : None, dosed neat.
- Treatment of test material prior to testing (e.g. warming, grinding):

FORM AS APPLIED IN THE TEST :The test article was dosed neat.

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hilltop Lab Animals, Inc.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 12 weeks
- Weight at study initiation: 226-237 g
- Fasting period before study: 16-20 hours prior to dosing
- Housing: Animals were individually and group housed in stainless steel or plastic suspended cages identified by a card indicating the lab number, animal numbers, test code, sex and date dosed.
- Diet (e.g. ad libitum): A commercially available rodent feed, PROLAB RMH 1000 - 5P07, was provided daily.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 30 days
- Microbiological status when known : No data
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 8 May, 2015 To: 22 May, 2015

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: NA, dosed neat.

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION (if unusual): The test article was dosed neat.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:The test article was not expected to be acutely lethal so a starting dose of 2,000 mg/kg was selected.

Doses:

2,000 mg/kg.

No. of animals per sex per dose:

5 females were dosed.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded at dosing and at 14 days for survivors.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: Animals were observed immediately after dosing, at 4 hours, and daily for up to 14 days for signs of illness or mortality. Body weights were recorded at dosing and at 14 days for survivors.
- Other examinations performed: clinical signs, body weight,gross necropsy.

Statistics:

Mean body weights for all animals will be calculated at dosing and for survivors at day 14. Statistical manipulation of data is not applicable to this study.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the 14 day study.

Clinical signs:

other: No clinical signs were observed that were related to test article administration.

Gross pathology:

No macroscopic findings were noted upon necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, the acute oral LD50 of MDP is greater than 2,000 mg/kg body weight.

Executive summary:

The acute oral toxicity of MDP was evaluated in female Wistar rats. This study was performed in accordance with US FDA GLP. The study design was based on OECD 423 (2001) and ISO 10993-11: 2006. Five female rats received 2,000 mg/kg MDP via oral gavage at approximately 2 mL/kg (density = 1.002 g/mL). The rats were observed through 14 days post-dose. Body weights were recorded pretest and at termination. All animals were examined for gross pathology. All animals survived. There were no abnormal clinical observations, body weight changes or necropsy findings in any animals. Based on the results of the study, the acute oral LD50 of MDP is greater than 2,000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Justification for classification or non-classification

Based on the results of the study, MDP does not meet the GHS classification criteria for acute oral toxicity.