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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
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

Constituent 1
Chemical structure
Reference substance name:
Glycerol trinitrate
EC Number:
200-240-8
EC Name:
Glycerol trinitrate
Cas Number:
55-63-0
Molecular formula:
C3H5N3O9 C3H5(NO3)3
IUPAC Name:
propane-1,2,3-triyl trinitrate
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 or test system 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
ca. 0.46
Max. score:
5
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
ca. 0.46
Max. score:
5
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
ca. 0.46
Max. score:
5
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
ca. 0.46
Max. score:
5
Reversibility:
not specified
Remarks on result:
probability of mild irritation

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