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Diss Factsheets

Administrative data

Description of key information

Irritation studies for skin and eye were conducted in rabbits with an aqueous formulation containing 78-80% active ingredient, demonstrating that the test material was a skin irritant and causing serious damage  to the eye.  There were no scores available for both dermal and eye irritation, however based on the category findings, the test item is considered irritating for skin (CLP category 2) and causing severe eye damage (CLP category 1).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP compliance, however, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FHSA, 16cfr1500.41 CPSC
Principles of method if other than guideline:
FHSA: Federal Hazardous Substances Act
CPSC: Consumer Product Safety Commission
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
Not provided
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
2.5, 5 and 10 mL/kg bw (corresponding to +- 9, 18 and 36 mL or gram)
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
13
Irritation parameter:
erythema score
Basis:
animal: #1 (H815)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 3 days to death)
Irritation parameter:
erythema score
Basis:
animal: #2 (H817)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 2 days to death)
Irritation parameter:
erythema score
Basis:
animal: #3 (H818)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 2 days to death)
Irritation parameter:
erythema score
Basis:
animal: #4 (H819)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; less than 1 day to death)
Irritation parameter:
erythema score
Basis:
animal: #5 (H821)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; less than 1 day to death)
Irritation parameter:
erythema score
Basis:
animal: #6 (H823)
Time point:
other: not specifed
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #7 (H824)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 4 days to death)
Irritation parameter:
erythema score
Basis:
animal: #8 (H825)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #9 (H826)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #10 (H832)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #11 (H833)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 4 days to death)
Irritation parameter:
erythema score
Basis:
animal: #12 (H835)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #13 (H836)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
edema score
Basis:
animal: #1 (H815)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #2 (H817)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #3 (H818)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #4 (H819)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #5 (H821)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #6 (H823)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #7 (H824)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #8 (H825)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #9 (H826)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #10 (H832)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #11 (H833)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #12 (H835)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #13 (H836)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritant / corrosive response data:
No scores available
Interpretation of results:
irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
At the dose of 10 mL test item/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL test item/kg bw, erythema and edema were initially quite severe, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days.
Executive summary:

Single doses of the test item containing 80% active ingredient were applied to the closely-clipped skin of male rabbits for 24 hours under occlusion. Doses given were 2.5, 5 and 10 mL test item/kg body weight, corresponding with ca. 9, 18 and 36 g active ingredient. At the dose of 10 mL/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL/kg bw, erythema and edema were initially quite severe, but the edema subsided wihtin 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. The 2 latter doses were considered as worst case situation volumes (9 and 18 g instead of 0.5 g), therefore the substance is considered to be irritating but not corrosive to skin. There were no scores available.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
1957
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP compliance, however, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
dose of 0.05mL, observation period of 7 days (not until reversibility), no detailed scoring done
GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
Not provided
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.05 mL of Aerosol MA-80%
Duration of treatment / exposure:
The lids of the left eye were held close for 30 seconds following introduction in the eye.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
5 male albino rabbits
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
2
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
3
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: at intervals over the next several days
Max. score:
4
Remarks on result:
other: classification (no scores provided in the report)
Irritation parameter:
other: no scores provided in report
Max. score:
4
Remarks on result:
other: classification
Irritant / corrosive response data:
No scores available
Other effects:
There was an immediate reaction of pain, but by four hours after the dose no more serious signs of irritation than profuse discharge was observed. At observation on the following day, the discharge had lessened somewhat, but a moderate degree of conjunctivitis had developed, together with extreme swelling of the lids in two instances. The intensity of these reactions was variable within the group, so that in the case of the two animals noted the severity of irritation was considerably more pronounced than with the others, and, in addition, they displayed signs of corneal involvement characterized by diffuse clouding of the entire area. These differences in response are probably attributable to differences in amount of the dose washed out by the initial discharge. However, by the fourth day the pattern of injury was well-developed in all eyes and consisted of moderate discharge, partial closing of the lids by swelling, moderate conjunctivitis, sluggish reaction of the iris to light, and diffuse corneal opacity. This condition persisted with no appreciable improvement for the reminder of a 7-day observation period.
Interpretation of results:
irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In common with other anionic surface-active agents, this test item, as a concentrated solution, is severely irritating to rabbit eyes, producing injury that is slow to heal.
Executive summary:

A volume of approximately 0.05 mL of the test item containing 80% active ingredient was instilled into the conjunctival sac of the left eye of each of 5 male albino rabbits. The lids were held closed for about 30 seconds following introduction of the dose, and the eye was examined immediately thereafter, and again over the next several days. There was an immediate reaction of pain, but by four hours after the dose no more serious signs of irritation than profuse discharge was observed. At observation on the following day, the discharge had lessened somewhat, but a moderate degree of conjunctivitis had developed, together with extreme swelling of the lids in two instances. The intensity of these reactions was variable within the group, so that in the case of the two animals noted the severity of irritation was considerably more pronounced than with the others and, in addition, they displayed signs of corneal involvement characterized by diffuse clouding of the entire area. These differences in response are probably attributable to differences in amount of the dose washed out by the initial discharge. However, by the fourth day the pattern of injury was well-developed in all eyes and consisted of moderate discharge, partial closing of the lids by swelling, moderate conjunctivitis, sluggish reaction of the iris to light, and diffuse corneal opacity. This condition persisted with no appreciable improvement for the reminder of a 7-day observation period. There were no scores available.

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A key in vivo skin irritation study (Shaffer, 1957) was available where single doses of the registered substance containing 80% active ingredient were applied to the closely-clipped skin of male rabbits for 24 hours under occlusion. Doses given were 2.5, 5 and 10 mL test item/kg body weight, corresponding with ca. 9, 18 and 36 g active ingredient. At the dose of 10 mL/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL/kg bw, erythema and edema were initially quite severe, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. The 2 latter doses were considered as worst case situation volumes (9 and 18 g instead of 0.5 g), therefore the test item is considered to be irritating but not corrosvie to skin. There were no scores available.

Eye irritation

A key study for eye irritation was conducted similar to OECD 405 method (Shaffer, 1957), where 0.05 mL of the registered substance containing 80% active ingredient was instilled into the conjunctival sac of the left eye of each of 5 male albino rabbits. There was an immediate reaction of pain, but by four hours after the dose no more serious signs of irritation than profuse discharge was observed. At observation on the following day, the discharge had lessened somewhat, but a moderate degree of conjunctivitis had developed, together with extreme swelling of the lids in two instances. The intensity of these reactions was variable within the group, so that in the case of the two animals noted the severity of irritation was considerably more pronounced than with the others and, in addition, they displayed signs of corneal involvement characterized by diffuse clouding of the entire area. These differences in response are probably attributable to differences in amount of the dose washed out by the initial discharge. However, by the fourth day the pattern of injury was well-developed in all eyes and consisted of moderate discharge, partial closing of the lids by swelling, moderate conjunctivitis, sluggish reaction of the iris to light, and diffuse corneal opacity. This condition persisted with no appreciable improvement for the reminder of a 7-day observation period. There were no scores available.

Further information supporting the classification is provided in the read across justification for the Diester category, showing that all substances in the group (except 1 which was not irritating) were irritating for skin and all were group classified to cause severe eye damage (justification with data matrix separately attached in Section 13).


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
key study

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the results the test item containing 80% active ingredient needs to be classified for skin irritation according to CLP regulation (No. 1272/2008 of 16 December 2008) as Category 2, with signal word 'Warning' and hazard statement: H315 -Causes skin irritation. 


Based on the results and read across with category member(s), the test substance containing 80% active ingredient is classified according to CLP regulation (No. 1272/2008 of 16 December 2008) as Category 1, with signal word 'Danger' and hazard statement: H318 -Causes serious eye damage.