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Diss Factsheets

Administrative data

Description of key information

In a skin irritation study (Younger Laboratories, 1965), undiluted Dequest 2010 was applied to the intact skin or abraded skin of rabbits for 24 hours under an occlusive dressing (the report does not describe how the intact and abraded sites were positioned on the rabbits). The skin reactions were then observed for up to 168 hours. Well-defined redness with one instance of very slight oedema was noted after one hour. Overnight there was moderate erythema and slight oedema with an average score of 3.6. Following removal of the test substance after 24 hours, inflammation gradually reduced to two instances of very slight redness in 7 days. Tissue necrosis occurred when the test substance was in contact with abraded areas for 24 hours. Therefore it was concluded that Dequest 2010 was moderately irritating to the skin of rabbits.

 

In an eye irritation study (Younger Laboratories, 1965), undiluted Dequest 2010 was instilled into the eyes of 3 rabbits. The eyes of animals 1 and 2 were rinsed after 24 hours. The eye of animal 3 was washed after 4 seconds. After 24 hours exposure there was copious discharge, translucent cornea with iris details moderately obscured, particularly the lower half, moderately severe erythema, and swelling with partial eversion of the lids developed within 1 hour of instillation. After 24 and 48 hours corneal opacity increased and the conjunctivae became bright red. The lower half of the cornea became opaque within 72 hours and remained so throughout the 7 day observation period. With the lower portion of the iris invisible and not responding to light, it was evident that sight had been destroyed. After a 4 second exposure moderate lacrimation, mild oedema and erythema, and mild corneal cloudiness with iris details clearly visible were observed within an hour. Congestion increased slightly by 24 hours, but decreased thereafter with only very slight redness remaining after 7 days. Dequest 2010 was considered to be corrosive to eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only an summary report was available for review.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Conducted prior to adoption of OECD test guidelines.
Deviations:
yes
Remarks:
Limited information on test material, methodology and environmental conditions. Guideline exposure period is 4 hours, not 24.
Principles of method if other than guideline:
Method: other: Insufficient detail to fully assess comparability with OECD guideline.
GLP compliance:
no
Remarks:
Conducted prior to adoption of GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data
Type of coverage:
not specified
Preparation of test site:
other: Intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml (equivalent to 435 mg active acid. Although the recommended dose of 0.5 ml was achieved for the formulation, this means that the limit dose for the active acid was not attained. The level of irritation of the anhydrous active acid may therefore be underestimated by this study).

Duration of treatment / exposure:
24 hour(s)
Observation period:
Seven days (at 4, 24, 48, 72 and 168 hours)
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: No data


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data


SCORING SYSTEM: No data
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: All
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No oedema or erythema in any animal, at any time point.
Other effects:
None reported.
Interpretation of results:
GHS criteria not met
Conclusions:
In a briefly summarised skin irritation study (reliability score 4), conducted prior to the adoption of OECD test guidelines and GLP, undiluted Dequest 2010 was not irritating to the skin of rabbits.
Executive summary:

Undiluted Dequest 2010 (0.5 ml) was applied to the skin (summary table not clear, but appears that test was conducted on intact and abraded skin) of six New Zealand white rabbits for 24 hours (type of dressing not specified). The skin was then observed for signs of irritation for seven days. No signs of irritation were observed in any of the animals tested, and it was concluded that Dequest 2010 was not irritating to the skin of rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study did not meet current guideline requirements for testing potential for skin irritation. It does, however, add weight of evidence for skin irritation.
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: other: Insufficient detail to fully assess comparability with OECD guideline.
GLP compliance:
no
Remarks:
Conducted prior to adoption of GLP
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
other: clipped intact or abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hour(s)
Observation period:
Seven days (1, 24, 48, 72, 120 and 168 hours)
Number of animals:
Three
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 24 hours
Score:
3.6
Max. score:
8
Reversibility:
not fully reversible within: seven days
Remarks on result:
other: Intact skin: only very slight redness on Day 7. Individual scores for erythema and oedema not reported.
Other effects:
Tissue necrosis occurred when the test substance was in contact with abraded areas for 24 hours. 

Table 1 Irritation scores for three test animals for intact skin

 Animal                 Numerical Evaluation at time point (h)
   1  24  48  72  120  168
 1  2  3  3  2  1  0
 2  3  4  3  3  2  1
 3  2  4  3  3  2  1
 Average  2.3  3.6  3.0  2.6  1.6  0.6

Results do not show responses from intact and abraded skin separately and do not distinguish between erythema/eschar formation and oedema formation.

Interpretation of results:
study cannot be used for classification
Conclusions:
In a limited skin irritation study (reliability score 4) conducted prior to the adoption of OECD test guidelines and GLP, Dequest 2010 was moderately irritating to rabbit skin.
Executive summary:

In a limited skin irritation study (reliability score 4) conducted prior to the adoption of OECD test guidelines and GLP, undiluted Dequest 2010 was applied to the clipped intact skin or abraded skin of three rabbits for 24 hours under an occlusive dressing (the report does not describe how the intact and abraded sites were positioned on the rabbits). The skin reactions were then observed at 1, 24, 48, 72, 120 and 168 hours. Well-defined redness with one instance of very slight oedema was noted after one hour. Overnight there was moderate erythema and slight oedema with an average score of 3.6. Following removal of the test substance after 24 hours, inflammation gradually reduced to two instances of very slight redness in seven days. Tissue necrosis occurred when the test substance was in contact with abraded areas for 24 hours. Therefore it was concluded that Dequest 2010 was moderately irritating to the skin of rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study meets generally accepted scientific principles, but was not conducted in compliance with GLP.
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: other: Insufficient detail to fully assess comparability with OECD guideline.
GLP compliance:
no
Remarks:
Conducted prior to adoption of GLP
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml (although the recommended dose of 0.1 ml was achieved for the formulation, this means that the limit dose for the active
acid was not attained).
Duration of treatment / exposure:
up to 24 hour(s)
Observation period (in vivo):
Seven days (skin reactions scored at 1, 24, 48, 72, 120 and 168 hours)
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, all animals with warm isotonic saline
- Time after start of exposure: 24 hours for animals 1 and 2, and four seconds for animal 3.


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: No data
Irritation parameter:
other: maximum irritation score
Basis:
animal: average of1 and 2
Time point:
other: from all time points
Score:
ca. 90
Max. score:
110
Reversibility:
not reversible
Remarks on result:
other: 24 hours exposure
Irritant / corrosive response data:
24 hour exposure: Copious discharge, translucent cornea with iris details moderately obscured, particularly the lower half, moderately severe erythema, and swelling with partial eversion of the lids developed within one hour of instillation. After 24 and 48 hours corneal opacity increased and the conjunctivae became bright red. The lower half of the cornea became opaque within 72 hours and remained so throughout the seven day observation period. With the lower portion of the iris invisible and not responding to light, it was evident that sight had been destroyed. The upper half of the eye was only moderately affected due to the fact that the dose was concentrated in the conjunctival sac.

4 second exposure: After one hour there was moderate lacrimation, mild oedema and erythema, and mild corneal cloudiness with iris details clearly visible. Congestion increased slightly by 24 hours, but decreased thereafter with only very slight redness remaining after seven days.
Other effects:
Discomfort immediately following instillation.

Table 1 Summary of Eye Irritation

  Animal                 Evaluation time point
   1  24  48  72  120  168
 24 hour exposure            
 1  42  57  75  90  90  90
 2  49  69  83  90  90  90
 Average  45.5  63  79  90  90  90
 4 second exposure            
 3  31  36  29  22  13  4



Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In an eye irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines and GLP, Dequest 2010 was corrosive to the eyes of rabbits.
Executive summary:

In an eye irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines and GLP, 0.1 ml undiluted Dequest 2010 was placed into the conjunctival sac of the right eye of each of three albino rabbits. The eyes of animals 1 and 2 were rinsed with warm isotonic saline after 24 hours exposure. The eye of animal 3 was washed after four seconds. Observations were made for seven days, and reactions scored according to the method of Draize. After 24 hours exposure there was copious discharge, translucent cornea with iris details moderately obscured, particularly the lower half, moderately severe erythema, and swelling with partial eversion of the lids developed within one hour of instillation. After 24 and 48 hours corneal opacity increased and the conjunctivae became bright red. The lower half of the cornea became opaque within 72 hours and remained so throughout the seven day observation period. With the lower portion of the iris invisible and not responding to light, it was evident that sight had been destroyed. The upper half of the eye was only moderately affected due to the fact that the dose was concentrated in the conjunctival sac. After a four second exposure moderate lacrimation, mild oedema and erythema, and mild corneal cloudiness with iris details clearly visible were observed within an hour. Congestion increased slightly by 24 hours, but decreased thereafter with only very slight redness remaining after seven days. Dequest 2010 was considered to be corrosive to the eyes of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

With a pH <2, the acid would be predicted to be severely irritating, if not corrosive to the skin. However, based on the available data, the acid is not expected to be significantly irritating to the skin. However, the limit dose for the active acid was not achieved and therefore the irritation might have been underestimated.


Justification for classification or non-classification

Based on the available data no classification for skin irritation is required for HEDP-H. Classification for irreversible eye damage Category 1 'H318: Causes serious eye damage' is required according to Regulation 1272/2008.