Lanolin, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Principles of method if other than guideline:

Acute oral toxicity was determined according to the procedure suggested by Hagan, E.C. (1959).

Hagan, E.C. (1959). Acute toxicity; Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 17-25.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lanolin, hydrogenated

EC Number:

232-452-1

EC Name:

Lanolin, hydrogenated

Cas Number:

8031-44-5

Molecular formula:

UVCB: not available

IUPAC Name:

Lanolin, wool wax, hydrogenated

Test animals

Species:

rat

Strain:

Wistar

Remarks:

albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 188-238 g.
- Fasting period before study: overnight.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum 7 days.

ENVIRONMENTAL CONDITIONS: maintained under standard laboratory conditions.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

5.0 g/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Observations: animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours post-dosage. Observations were made daily thereafter to a total of 14 days.
- Necropsy of survivors: animals sacrificed at the end of the 14-day observation period were subjected to complete gross necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: No clinical signs were noted.

Gross pathology:

no gross changes observed

Any other information on results incl. tables

Observations and measurements of body weight of the tested animals during the observation period are presented in the table below.

Table

Dose (g/kg)	Animal no and sex	Body weight (g)	Hours				Days							Body weight (g)
			1	3	6	24	2	3	4	5	6	7	-14
5	1 M	210	N	N	N	N	N	N	N	N	N	N	N	318
	2 M	220	N	NO CHANGE OBSERVED										230
	3 M	208	N											292
	4 M	218	N											354
	5 M	214	N											308
	6 F	206	N											270
	7 F	218	N											282
	8 F	206	N											248
	9 F	204	N											252
	10 F	192	N											242

N=Normal

D=Depression

SD=Slight Depression

XD=Severe Depression

+ = Animal Death

Applicant's summary and conclusion

Interpretation of results:

other: not classified as toxic/harmful according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 > 5000 mg/kg b.w.

Executive summary:

The acute oral toxicity of the test material was tested in a limit test according to according to the procedure suggested by Hagan, E.C. (1959). Five male and five female Wistar-derived albino rats were orally administered the substance, at 5000 mg/kg b.w. During the 14 -day observation period, mortality, body weight, signs of pharmacologic activity and drug toxicity were noted. All surviving animals were sacrificed and were subjected to complete gross necropsy.

No substance-related findings, gross pathological changes or mortality was observed during the study. The body weight for both males and females was increased after 14 days.

LD50 > 5000 mg/kg b.w.