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Diss Factsheets

Administrative data

Description of key information

The irritating behaviour of the substance has been determined in adequate studies in the rat and rabbits by application of the substance into the skin and into the eye. No studies are available for respiratory irritation.

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:
1973
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in foods drugs and cosmetics (1959) AFDO
Principles of method if other than guideline:
Similar to OECD 404 (pre-GLP)
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 1.6 kg
- Housing: Singly in metal cages, overall dimensions 47x32x34 cm
- Diet (e.g. ad libitum): Nafag
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +- 1
- Humidity (%): 55 +- 5
- Photoperiod (hrs dark / hrs light): 14 hrs light day

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6 rabbits, 3 males and 3 females
Details on study design:
The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediatly to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape.
FAT 11 030/A was applied to each side in quantities of 0.5 g. Before application the test material was wetted with tap water.
The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days on the basis of erythema and edema formation.
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 24 hours
Score:
> 0.7 - < 3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 24 hours
Score:
> 0.7 - < 2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 48 hours
Score:
> 0.3 - < 2.3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 48 hours
Score:
> 0.3 - < 1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 72 hours
Score:
> 0.3 - < 2
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 4 days
Score:
> 0.3 - < 1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 4 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 8 days
Score:
> 0 - < 0.6
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 8 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 8 days

Results tabulated to follow indications according to Guidance on the application of CLP criteria

                  observation time    
   24h  48h  72h  24h  48h  72h          positive >=2.3?          
 animal number        erythema        oedema  mean erythema mean oedema               
 1  1  1  1  1  1  1  1  1  no            
 2  2  1  1  2  1  1  1.3  1.3  no            
 3  2  2  1 2   1  1  1.7  1.3  no            
 4  2  1  1  2 1   0  1.3 1   no            
 5  1  1  0  1  0  0  0.7  0.3  no            
 6  0  0  0  0  0  0  0  0  no            
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
The original study applied criteria US CPSC/US FDA and classified the substance as "moderately irritating".
Preparation of the substance was found to cause minimal irritation (mean reaction score after 24 hours: 0.7) when applied to intact but moderate irritation when applied to abraded rabbit skin (mean reaction score after 24 hours: 2.7).
Executive summary:

6 rabbits (3 males and 3 females) of the Russian breed were dosed with substance in quantities of 0.5 g to the shaved skin area in order to find out the primary irritation index. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days.

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:
1993
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Age at study initiation:
- Weight at study initiation: 2230 to 2620 g
- Housing: individually
- Diet (e.g. ad libitum): libitum standard rabbit pellet
- Water (e.g. ad libitum): fresh water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3°C
- Humidity (%): 30-70%
- Air changes (per hr): Unknown
- Photoperiod (hrs dark / hrs light): 12 hours light

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml (32 mg) of FAT 11030/B were applied into the conjunctival sac of the left eye of each animal.

- The right eye remained untreated and served as control
Duration of treatment / exposure:
After instillation the lids were held together for about on second to prevent loss of the test article.
Observation period (in vivo):
Ocular reaction were evaluated after 1, 24, 48 and 72 hours after instillation
Reaction was observed after 7, 10 and 14 days of the instillation
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:

Cornea
A.- Opacity-degree of density
No opacitiy 0
Scaterred or difussed area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible 3
Opaque, iris invisible 4

B.- Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4

AxBx5 Total maximum=80

Iris
A.- Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection 1
No reaction to light, hemorrhage, gross destruction 2

Ax5 Total maximum=10

Conjuctivae
A.- Redness
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not 2
easily discernible
Diffuse beefy red 3

B.- Chemosis
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C.- Discharge
No discharge 0
Any amount different from normal 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable 3
area around the eye

(A+B+C)x2 Total maximum=20

TOOL USED TO ASSESS SCORE: A slit-lamp was used to facilitate the evaluation .
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
658/F
Time point:
other: 24-72 hours
Score:
> 0 - < 0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
658/F
Time point:
other: 24-72
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
658/F
Time point:
other: 24-72 hours
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
658/F
Time point:
other: 24-72 hours
Score:
> 0 - < 0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
110/F
Time point:
other: 24-72 hours
Score:
> 0 - < 0.67
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
110/F
Time point:
other: 24-72 hours
Score:
> 0 - < 0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
110/F
Time point:
other: 24-72 hours
Score:
> 0 - < 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
110/F
Time point:
other: 24-72 hours
Score:
> 0 - < 0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
098/F
Time point:
other: 24-72 hours
Score:
> 0 - < 0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
098/F
Time point:
other: 24-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
098/F
Time point:
other: 24-72 hours
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
098/F
Time point:
other: 24-72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EEC classification of the results obtained 24 to 72 hours after instillation of the substance, it can be classified as non-irritant to albino rabbit's eye. Changes fully reversible within 14 days.
Executive summary:

Under the experimental conditions employed the test material induced reactions of the cornea, iris and conjunctiva when instilled into the conjunctival sac of albino rabbits' eyes.

The following mean scores (24 - 72h) were calculated:

Animal No   658  110  098
 Conjunctiva/redness  1 2  1 
 Conjunctiva /chemosis  0.33 0.33  0 
 Cornea 0.33  0.67 0.33 
 Iris 0 0.33   0
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For skin irritation/corrosion there are two studies available. Both of them were performed following test methods similar to OECD 404 (pre-GLP and non-GLP). In the study of Thomann P (1973) the test material used for testing was CAS 1325-54-8 / EC 215-397-8. The substance was applied to intact and abraded skin of 6 rabbits. In the intact skin the mean reaction score was 0.7 (24h) and in the abraded skin the value was 2.7 (24h). The effects are reversible and after 8 days there were reduced to mean reaction score 0 (intact skin) and to 0.6 (abraded skin). The substance was classified as moderately irritant according to the USA/FDA criteria.

The results have been evaluated according to EU/CLP criteria and following the Guidance on Application of CLP Criteria, the conclusion is that the substance is not skin irritant. Evaluation has been made based on the average score per animal using the results of the original study. Any of the animals has reached the cut-off value of 2.3. No classification is warranted with regard to skin irritation according to CLP Regulation.

In a recent study of Alvarez i Genoher N (2002), the test material used was CAS1195028-55-7, a substance of identical structure to CAS 1325-54-8 / EC 215-397-8 in respect of the anionic components. This substance didn't show irritating properties when applied to skin of rabbits. This result of this study supports the classificacion as non irritant.

There are no studies available for respiratory irritation.

For eye irritation determination there are two studies available. Study of Hagemann CH (1993) was done according to OECD405 and is GLP compliant. Supporting study of Thomann P (1973) was done with a similar method to OECD, non-GLP compliant. In this study, 6 rabbits have been used and the results obtained have been checked and compared to criteria as described in the Guidance on application of CLP criteria. In both cases the results showed that the substance provoques a certain effect irritation after application of the substance to eyes of rabbits, but the effects are fully reversible after 14 days.

Based on both results the substance is considered as non-irritant to eyes in order to do the chemical safety assessment as well as for classification purposes.


Justification for selection of skin irritation / corrosion endpoint:
Two available studies with same results following CLP criteria.

Justification for selection of eye irritation endpoint:
Two available studies with same results.

Justification for classification or non-classification

Skin irritation: For classification purposes the results in the study report of Thomann (1973), have been reviewed following the indications on the Guidance on application of CLP criteria November 2012. The mean score per animal for erythema/eschar or for oedema doesn't fall into the range for classification of the substance as skin irritant according to CLP Regulation(EU Regulation 1272/2008). The substance is not classified as skin irritant according to EU Directive 67/548/EEC.

Based on the results of available studies on eye irritation CAS 1325-54-8 / EC 215-397-8 was not classified as eye irritant according to the EU DSD classification criteria (EU Directive 67/548/EEC). According to the EU CLP classification criteria (EU Regulation 1272/2008), CAS 1325-54-8 / EC 215-397-8 is also not classifed as eye irritant.