Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-06-04 - 2015-07-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanomaterial

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals 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:
> 5 000 mg/kg bw
Mortality:
5000 mg/kg bw: female: 0/10, male: 0/10
Clinical signs:
no sign of systemic toxicity detected

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Conclusions:
For the test item graphene the oral LD50 of both male and female mice is higher than 2000 mg/kg bw.
Executive summary:

Acute oral toxicity was analyzed 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 guideline 420. Ten male and female ICR mice received doses of 5000 mg/kg bw graphene by gavage. Since no acute toxicity was observed at 5000 mg/kg b.w., the LD50 was found to be >2000 mg/kg b.w. and therefore a classification according to Regulation (EC) 1272/2008 is not warranted.