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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1.4.1974-31.5.1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets National standards method with acceptable retrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register, Title 21-Food and Drugs, Part 191,11 "Method of Testing Primary Irritant Substances" and Part 191,12 "Test for Eye Irritants" (1974).
GLP compliance:
not specified
Remarks:
Unlikely.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trinitroglycerin (TNG, NG)- Substance type: organic substance- Physical state: a 10% mixture in lactose- Source: ICI America-Atlas Chemical Division (Chicago Illinois)- Analytical purity: 9.72 % +/- 0,09% in lactose

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Sma´l Stock Industries (Pea Ridge, Arkansas)- Housing: metal cages with wire bottoms- Diet (e.g. ad libitum): Purina rodent chow ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 23.9 +/- 2.8 oC- Humidity (%): 50 +/- 10%- Photoperiod (hrs dark / hrs light): photoperiod of 12 hours

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
other: peanut oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL- Concentration (if solution): 9.72%VEHICLE- Concentration (if solution): 25% peanut oil and 67.21% lactose
Observation period:
24 h, 72 h
Number of animals:
Six rabbits with intact and abraded skin.
Details on study design:
SCORING SYSTEM:The compounds are classified as follows:> 0.2 over controls is mild irritant> 2.5 over controls is moderate irritant> 5.0 over controls is severe irritant

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h, 72 h
Score:
0.46
Max. score:
5

Any other information on results incl. tables

The more detailed information about results are not available.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information