Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically well-performed study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): Aromox C/12
- Molecular formula (if other than submission substance): 36% in water

Test animals / tissue source

Species:
rabbit
Strain:
other: reported as "male albino rabbit"

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
the test material corresponds to 36% registration substance in water
Controls:
not required
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
up to seven days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24h
Score:
8.3
Max. score:
12
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48h
Score:
11.8
Max. score:
29
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72h
Score:
22
Max. score:
41
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 96h
Score:
32.8
Max. score:
61
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 168h
Score:
41.2
Max. score:
86

Any other information on results incl. tables

Rabbit eye irritation scores: Rabbit no. 1           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  5  0
 Iris  0  0  0  5  5  5
 Conjuctivae  6  8  8  6  4  4
 Total  6  8  8  16  14  9

Rabbit eye irritation scores: Rabbit no. 2          
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  20  45
 Iris  0  0  0  5  5  5
 Conjuctivae  8  8  14 14  12  16
 Total  8  8 14  24  37  66

Rabbit eye irritation scores: Rabbit no. 3           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  0  0  0
 Iris  0  0  0  5  5  5
 Conjuctivae  6  8 6  8  6  6
 Total  6  8  6  13  11  11

Rabbit eye irritation scores: Rabbit no. 4           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  10  20  40 60
 Iris  0  0  5  5  5  10
 Conjuctivae  6  12  14  16  16  16
 Total  6  12  29  41 61 86

Rabbit eye irritation scores: Rabbit no. 5          
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  20  30
 Iris  0  0  0  5  5  5
 Conjuctivae  6  8  8  10  12  14
 Total  6  8  8  20  37  49

Rabbit eye irritation scores: Rabbit no. 6           
                  Hours after treatment [h]
   1  24  48  72  96  168
 Cornea  0  0  0  5  20  10
 Iris  0  0  0  5  5  5
 Conjuctivae  6  6  6  8  12  14
 Total  6  6  6  18  37  29

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The registration substance at 36% was investigated for its eye irritation property equivalent to OECD 405. Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.
Executive summary:

The registration substance at 36% was investigated for its eye irritation property equivalent to OECD 405. Scores of uo to 86 (MMTS) were obtained and there was no indication of recovery within the observation period of 168 hours.

It is justified to assign R 41 for the registration substance according to 67/548/EEC(DSD), or Eye Dam.1 according to GHS.