Registration Dossier

Administrative data

Description of key information

In a skin irritation study conducted according to OECD Test Guideline 404 and in compliance with GLP (ASTA Medica AG, 1992b), triethoxy(octyl)silane was irritating to the skin of rabbits. Irritation had completely reversed by day 10. There were no systemic effects.  

In an eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP (ASTA Medica AG, 1992c), triethoxy(octyl)silane was not irritating to the eyes of rabbits. There were no systemic effects.

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:
22.04.1992 to 15.05.1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
other: White russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, D-4802 Halle-Künsebeck
- Age at study initiation: Nine months
- Weight at study initiation: Males: 2.49 and 2.52 kg; Female: 2.76 kg
- Housing: Individually in stainless steel cages
- Diet: 120 g/day/animal
- Water: Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 42-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27.04.1992 To: 15.05.1992
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
Four hours
Observation period:
9/10 days after application (at 1, 24, 48 and 72 hours, then daily)
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: Dorsal area between shoulder and sacrum
- % coverage: No data, but was 6.25 cm2
- Type of wrap if used: Occlusive (patch made of the following layers: cellulose gauze, cellulose fabric coated with natural rubber, synthetic film glue; a bandage was then wrapped several times around the trunk to provide complete occlusion).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Four hours

SCORING SYSTEM: Gilman et al (1983) Relationship between the primary dermal irritation index and ocular irritation. J. Toxicol.-Cut. & Ocular Toxicol. 2, 107-117.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
5.1
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Mean scores for erythema for 24, 48 and 72 hours were at least 2.3 in all animals. The mean scores for edema for 24, 48 and 72 hours were at least 2.3 in 2/3 animals.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Table 1. Severe changes were noted in the animals. Erythema occurred in all three animals. In 2/3 animals there was moderate to severe (grade 3) erythema at one hour. At this time the erythema in the third animal was well-defined (grade 2), then at 24 hours it was moderate to severe (grade 3). These findings had completely disappeared by day 10 of the observation period. In addition, skin scales, which immediately peeled off, were observed in all three animals from day 7 onwards.

A moderate oedema (grade 3) was noted in two animals after one hour of patch removal. The edema was severe in the third animal (grade 4). These findings had reversed by day 10.
Other effects:
Systemic effects did not occur in any animals.

Table 1 Summary of skin irritation scores

  Skin reaction    Hours/days after exposure  Animal 1 scores Animal 2  scores Animal 3 scores
Erythema and eschar  1 hr   2  3  3
  24 hr   3  3  3
  48 hr   3  2  2
  72 hr   3  2  2
  4 d   3  2  2
  7 d   2  2  3
  9 d   1  0  1
  10 d   0    0
Edema   1 hr   3  3  4
  24 hr   3  3  3
  48 hr   2  2  2
  72 hr   2  2  1
  4 d   2  2  1
  7 d   1  2  2
  9 d   0  0  1
  10 d   0    0
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In an occlusive skin irritation study conducted according to OECD 404 and in compliance with GLP (reliability score 1) triethoxyoctylsilane was irritating to the skin of rabbits. Irritation had completely reversed by day 10. There were no systemic effects.
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:
05.05.1992 to 21.05.1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
other: white russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, D-4802 Halle-Künsebeck
- Age at study initiation: 8-10 months
- Weight at study initiation: Males: 2.58 kg; Females: 2.39 and 2.58 kg
- Housing: Individually in stainless steel cages
- Diet: Approx. 120 g/day/animal
- Water: Ad libitum
- Acclimation period: At least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20.0
- Humidity (%): 50-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11.05.1992 To: 21.05.1992
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
No rinsing
Observation period (in vivo):
Three days (including 1, 24, 48, 72 hours)
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Cliptrix pencil light
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
2
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: The eye irritation did not meet EU classification criteria.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Table 1. There were no changes to the cornea or iris. The conjunctiva of all three animals reacted with diffuse redness (grade 2). The finding had completely disappeared 48 hours after application. Slight swelling (grade 1) occurred in all three animals only one hour after application. In addition, discharge moistened lids and hair just adjacent to lids in one animal was observed one hour after application.
Other effects:
There were no systemic toxic effects in any of the animals.

Table 1 Summary of irritation scores

Reaction  Day/hours after exposure           Scores for each animal
     Animal 1  Animal 2  Animal 3
 Corneal opacity  1 h  0  0  0
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
 Area of cornea involved  1 h  0  0  0
   24 h  0  0 0
   48 h  0  0  0
   72 h  0  0  0
 Iris  1 h  0  0  0
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
 Conjunctival redness  1 h  2  2  2
  24 h   1  1  1
   48 h  0  0  0
   72 h  0  0  0
 Conjunctival Chemosis  1 h  1  1  1
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
 Discharge  1 h  0  0  2
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1) triethoxy(octyl)silane was not irritating to the eyes of rabbits. There were no systemic effects.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are two skin irritation studies with a reliability score of 1, both conducted in 1992. The key study was selected because it had a longer post-exposure period and demonstrated reversibility of the irritation, and therefore more closely met the current guideline. The second reliability score 1 study also showed the test substance to be irritating to the skin of rabbits, based on the presence of desquamation at the end of the observation period.

There are also two eye irritation studies with a reliability score of 1, both conducted in 1992. The key study was selected as it had a longer observation period. However, all three available studies showed that the test substance is not irritating to the eyes .


Justification for classification or non-classification

Based on the key data, triethoxy(octyl)silane is not classified for eye irritation according to Regulation (EC) No 1272/2008. Regarding skin irritation, this substance is classified as Skin Irrit. Cat. 2 with the hazard statement 'H315: Causes skin irritation'.