Graphene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 Jun 2015 to 17 Jul 2015

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

not specified

Remarks:

no information given

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

carbon

EC Number:

801-282-5

Cas Number:

1034343-98-0

Molecular formula:

Cx

IUPAC Name:

carbon

Test material form:

solid: nanoform

Test animals

Species:

mouse

Strain:

ICR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Laboratory Animal Center of Jiangsu University (Certificate: SCXK (SU) 2013-0011)
- Weight at study initiation: 18.3 - 22.0 g
- Fasting period before study: animals fasted overnight
- Housing: housed in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): free access to food (Rat and Mouse Common Formula Diet, supplied by Suzhou Shuangshi Laboratory Animal Feed Science Co.,Ltd. (Certificate: SUSISHENG (2009) 05032).
- Water (e.g. ad libitum): free access to drinking water
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 40 - 70 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5000 mg/kg bw: 10 female/ 10 male mice

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (5000 mg/kg bw)
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: within the first 4 hours, and thereafter at least once daily
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

5000 mg/kg bw: female: 0/10, male: 0/10

Clinical signs:

other: no sign of systemic toxicity detected

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

For the test item graphene the oral LD50 of both male and female mice is higher than 2000 mg/kg bw.

Executive summary:

Study design

Acute oral toxicity was analysed according to the Chemical toxicity test instruction (2005), Ministry of Health of the People's Republic of China, which is in large part equivalent to method described in OECD TG 420.

Ten male and female ICR mice received doses of 5000 mg/kg bw graphene by gavage.

Results and discussion

No acute toxicity was observed at 5000 mg/kg b.w., the LD50 was found to be >2000 mg/kg b.w.

Conclusion

A classification according to Regulation (EC) 1272/2008 is not warranted.