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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable; the test conduct fulfilled the requirements of the OECD TG 404 as adopted 2015 without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(as adopted 28 July 2015)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutaral
EC Number:
203-856-5
EC Name:
Glutaral
Cas Number:
111-30-8
Molecular formula:
C5H8O2
IUPAC Name:
glutaraldehyde
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Glutaraldehyde
- Physical state: clear liquid
- Lot/batch No.: ZA1955S4D1
- Other: following dilutions were used:
4% Glutaraldehyde in water
15% Glutaraldehyde in water
24% Glutaraldehyde in water
45% Glutaraldehyde in water

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc., Clemmons NC
- Age at study initiation: no data
- Weight at study initiation: 2126 to 2590 g
- Housing: single housed in suspended stainless steel caging with mesh floors
- Diet: Harlan Teklad Certified Global High Fiber Rabbit Diet®) #2031C, appr. 150 g/day
- Water: filtered tap water, ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 23-48 (Humidity was below the targeted lower limit for 3 days during the study. A portable humidifier was used to raise the humidity levels during this time.)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 4%, 15% and 24% Glutaraldehyde in water
Duration of treatment / exposure:
3 min, 1 hour and 4 hours (three test sites on each animal)
Observation period:
30-60 min, 24, 48 and 72 hours, 7, 10 and 14 days
Number of animals:
5 (all females; 1 for 24% Glutaraldehyde in water, 1 for 15% Glutaraldehyde in water and 3 for 4% Glutaraldehyde in water)
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: test substance was covered with 1-inch x 1-inch, 4-ply gauze pad. The pads and entire trunk of the animal were then wrapped with semi-occlusive 3-inch Micropore™ tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 3% soap solution followed by water and clean paper towels
- Time after start of exposure: 3 minute, 1 hour or 4 hours, respectively

SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(4-hour exposure)
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24h - 48h - 72h
Score:
2.87
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4% Glutaraldehyde in water
Irritation parameter:
edema score
Remarks:
(4-hour exposure)
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24h- 48h - 72h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
in 2 of 3 animals
Remarks on result:
other: 4% Glutaraldehyde in water
Irritation parameter:
erythema score
Remarks:
(3-minute exposure)
Basis:
animal #2
Time point:
other: 24h - 48h -72h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 15% Glutaraldehyde in water
Irritation parameter:
edema score
Remarks:
(3-minute exposure)
Basis:
animal #2
Time point:
other: 24h - 48h - 72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 15% Glutaraldehyde in water
Irritation parameter:
erythema score
Remarks:
(1-hour exposure)
Basis:
animal #2
Time point:
other: 24h - 48h - 72h
Score:
3
Max. score:
4
Reversibility:
other: euthanized after 72 hours
Remarks on result:
other: 15% Glutaraldehyde in water
Irritation parameter:
edema score
Remarks:
(1-hour exposure)
Basis:
animal #2
Time point:
other: 24h - 48h - 72h
Score:
3
Max. score:
3
Reversibility:
other: euthanized after 72 hours
Remarks on result:
other: 15% Glutaraldehyde in water
Irritation parameter:
erythema score
Remarks:
(4-hour exposure)
Basis:
animal #2
Time point:
other: 24h - 48h - 72h
Score:
3.7
Max. score:
4
Reversibility:
other: euthanized after 72 hours
Remarks on result:
other: 15% Glutaraldehyde in water
Irritation parameter:
edema score
Remarks:
(4-hour exposure)
Basis:
animal #2
Time point:
other: 24h - 48h - 72h
Score:
4
Max. score:
4
Reversibility:
other: euthanized after 72 hours
Remarks on result:
other: 15% Glutaraldehyde in water
Irritation parameter:
erythema score
Remarks:
(3-minute exposure)
Basis:
animal #1
Time point:
other: 24h
Score:
2
Max. score:
2
Reversibility:
other: euthanized after 24 hours
Remarks on result:
other: 24% Glutaraldehyde in water
Irritation parameter:
edema score
Remarks:
(3-minute exposure)
Basis:
animal #1
Time point:
other: 24h
Score:
2
Max. score:
2
Reversibility:
other: euthanized after 24 hours
Remarks on result:
other: 24% Glutaraldehyde in water
Irritation parameter:
erythema score
Remarks:
(1-hour and 4-hours exposure)
Basis:
animal #1
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
other: euthanized after 24 hours
Remarks on result:
other: 24% Glutaraldehyde in water
Irritation parameter:
edema score
Remarks:
(1-hour and 4-hours exposure)
Basis:
animal #1
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
other: euthanized after 24 hours
Remarks on result:
other: 24% Glutaraldehyde in water
Irritant / corrosive response data:
24% concentration (one animal tested = animal #1):
3-minute exposure and 24-hour observation period no corrosion was observed
1-hour exposure and 24-hour observation period corrosion was observed
4-hour exposure and 24-hour observation period corrosion was observed

15% concentration (one animal tested = animal #2):
3-minute exposure and 72-hour observation period no corrosion was observed
1-hour exposure and 72-hour observation period no corrosion was observed
4-hour exposure and 72-hour observation period corrosion was observed

4% concentration (three animals tested):
4-hour exposure and 14-day observation period no corrosion was observed in all three animals

Any other information on results incl. tables

Details on findings and scores:

24% Glutaraldehyde in water - Erythema/Edema             
Animal No. Exposure time  30-60 min after patch removalErythema/Edema  24 hours after removal of 4-hours patchErythema/Edema  Findings
 1  3 min 1/1*   2/2  
 1  1 hour  2/2*  4/4** * Dark yellow discolouration in and around the dose site. **Green discolouration in and/or around the dose site. Blanching in the dose site.
 1  4 hours  2/3*  4/4** * Dark yellow discolouration in and around the dose site. **Green discolouration in and/or around the dose site. Blanching in the dose site.

15% Glutaraldehyde in water - Erythema/Edema                  
Animal No.    Exposure time    30-60 min after patch removalErythema/Edema   After removal of 4-hour patchErythema/Edema        Findings   
24h 48h 72h
 2  3 min 1/0  1/0 1/0 1/0   
 2  1 hour 2/21  2/32   3/32 4/33,4 1 Yellow discoloration in the dose site.2 Green discoloration in the dose site.3 Hyperkeratosis present at the dose site.4 Dark brown discoloration in the dose site.    
 2  4 hours 2/42 3/42 4/42,3 4/43,4

4% Glutaraldehyde in water - Erythema/Edema                      
Animal No.    30-60 min after patch removal Erythema/Edema   After removal of 4-hour patch Erythema/Edema               
 24h 48h  72h  Day 7  Day 10  Day 14 
 3  2/31,2  2/43,4  4/43,4  4/43,4,5  3/23,5  4/23,5  4/13,5,6
 4  2/2  2/27 3/27   3/28  2/15,8  1/05,7  1/05,7
 5  2/2  2/37  3/37  3/38  2/25,8  1/25,7  1/25,7
 Total  6/7  6/9  10/9  10/9 7/5  6/4  6/3
 Mean  2.0/2.3  2.0/3.0  3.3/3.0  3.0/3.0  2.3/1.7 2.0/1.3   2.0/1.0
1 Greenish yellow discolouration in the dose site.2 Small light brown areas in the dose site.3 Area of brown discolouration in the dose site.4 Area of superficial eschar in the dose site.5 Hyperkeratosis present at the dose site.6 Shiny skin evident at the dose site.7 Light brown discolouration in the dose site.8 Dark brown discolouration in the dose site.                     

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the test conditions used, Glutaraldehyde 24% and 15% were corrosive and Glutaraldehyde 4% was irritating to the skin of rabbit.
Thus, Glutaraldehyde 24% and 15% are assigned R 34 according to EU classification and labelling, and are classified in Categories 1B and 1C "Corrosive" according to GHS (2005), respectively. Glutaraldehyde 4% is assigned R38 according to EU classification and labelling, and is classified in Category 2 "Irritant" according to GHS (2005).